Searching for Full Time Employment in Germany that offer work life balance
Aktualisiert am 31.05.2023
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.06.2023
Verfügbar zu: 100%
davon vor Ort: 100%
Good Clinical Practice
Clinical Research
Clinical Project
English
Excellent (written & oral)
Urdu
Excellent (written & oral)
Punjabi
Excellent (written & oral)
Arabic
Basic (written & oral)
German
Beginner (yet to learn)

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

7 months
2022-10 - 2023-04

delivery and management of clinical studies

Clinical Project (Trial) Manager
Clinical Project (Trial) Manager
  • Responsible for delivery and management of clinical studies, including multiple and full service, and multi-regional studies.
  • Develop integrated study management plans with the core project team.
  • Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies, and procedures.
  • Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy, and approach, effectively communicate, and assess performance.
  • Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
  • Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
  • Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
  • Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
  • May serve as primary or backup project contact with customer and would then own the relationship with the project?s key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.
  • Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.
  • Ensure the financial success of the project.
  • Forecast and identify opportunities to accelerate activities to bring revenue forward.
  • Identify changes in scope and manage change control process as necessary.
  • Identify lessons learned and implement best practices.
  • May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.
  • Adopt corporate initiatives and changes and serve as a change advocate when necessary.
  • Provide input to line managers of their project team members? performance relative to project tasks.
  • Support staff development and mentor less experienced project team members on assigned projects to support their professional development.
  • Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
IQVIA RDS GmbH, Bremen, Germany
Bremen
8 months
2021-10 - 2022-05

Coordination and control over the feasibility, start-up, clinical and site-management activities

Clinical Project Lead
Clinical Project Lead
  • Coordination and control over the feasibility, start-up, clinical and site-management activities related to a specific clinical trial within the Department;
  • Strict control over the compliance of study milestones: start, patients? enrolment (overall study) and timelines as per the contract obligations.
  • Control over budget, issue, task, and time management of the project/s under his/her supervision.
  • Communication with sponsors, partnering CROs, physicians, or regulatory authorities.
  • Manage the process of creation, approval all essential documents developed or tailored in-house as ICF, Patients Material, translated documents.
  • Responsible for distribution within the team of final approved version of all essential documents (Protocol, IB, CRF, ICF, etc.).
  • Initiate selection and approval, ongoing management and dealing with all third parties involved in the study.
  • Control over all logistic procedures related to the study.
  • Identify changes, work with team members to quantify financial / time impact and communicate those changes to appropriate personnel.
  • Assisting Dir. FND in contracting process, when required.
  • Control of submission/ approval process to EC/ RA in close collaboration with the clinical research associates.
  • Organization and performing of study team trainings, meetings, and customization of study-specific forms.
  • Develop and distribute to the team any study-specific manuals, instructions, and guidelines.
  • Ensure timely reports? review.
  • Coordinate activities between different stakeholders and determine interim study time points.
  • Providing any requested internal progress reports and completion of the relevant files.
  • Preparation and conducting of Investigator Meetings in close collaboration with Financial Dept.
  • Collaboration with internal/ external auditors, co-monitors, or regulatory inspectors in review of files and patient data.
  • Management of Third parties on study level for any subcontracting or external lab.
  • Execute any activities in compliance with applicable SOPs, instructions, and principles.
  • Develop Study Specific plans as PMP, monitoring plan, TMF maintenance plan, communication plan, quality plan, project risk matrix (if applicable).
  • Perform SCRA activities as per assigned clinical trials.
CTI Clinical Trial and Consulting Services, Inc., Riyadh, Saudi Arabia
1 year 9 months
2020-01 - 2021-09

plan, coordinate execution and accomplish clinical projects

Clinical Project Lead
Clinical Project Lead
  • To plan, coordinate execution and accomplish clinical projects under his/her responsibility in accordance with ICH GCP, applicable global & local SOPs, local regulations, ethics/compliance, and clinical practice.
  • Is accountable for coordination of study activities generated by clinical trial/studies, in compliance with the company quality standards and the regulations in force, the forecasted timelines, milestones and study budget.
  • Works closely with COM/key stakeholders and is responsible for the planning, set-up, progress & delivery, close/archiving through to eventual reporting of a clinical trial/study within the country.
  • Takes measures to ensure study conduct ultimately protects the rights and well-being of participating patients/subjects & trial data integrity and credibility.
  • Takes ownership and accountability to remain abreast & aware of applicable training/SOPs/processes required for the conduct of clinical operations/related activities within defined timelines.
  • Ensures that the clinical study / trials are conducted within committed targets and timelines (including fiscal) from study planning through to study completion & archiving.
  • Supports/ Mentors assigned CRA study on-boarding/training, including study site handover oversight & monitors study site progress with CRA.
  • Represents the country at the regional CTT (Clinical Trial Team) and local MT (monitoring team) and is the main contact for the Regional Trial Manager (RTM) or Clinical Trial Operations Manager (CTOM) &/ Trial Supply Operations Manager (TSOM).
  • Ensures collaboration with other CTT and local extended Study Management Team members/stakeholders (e.g., Medical Managers/Advisors, etc), as deemed appropriate with timely & effective information exchange.
  • Consistently demonstrates the skills necessary for effective communication, teamwork, motivating people towards the common study goals & positively influences transversal ways of working within a matrix environment.
  • Investigational Medicinal Product (IMP) Manager: Ensures the IMP process locally.
COVANCE Inc./RAY Alliance
4 months
2019-09 - 2019-12

plan, coordinate execution and accomplish clinical projects

Clinical Project Lead
Clinical Project Lead
  • To plan, coordinate execution and accomplish clinical projects under his/her responsibility in accordance with ICH GCP, applicable global & local SOPs, local regulations, ethics/compliance, and clinical practice.
  • Is accountable for coordination of study activities generated by clinical trial/studies, in compliance with the company quality standards and the regulations in force, the forecasted timelines, milestones and study budget.
  • Works closely with COM/key stakeholders and is responsible for the planning, set-up, progress & delivery, close/archiving through to eventual reporting of a clinical trial/study within the country.
  • Takes measures to ensure study conduct ultimately protects the rights and well-being of participating patients/subjects & trial data integrity and credibility.
  • Takes ownership and accountability to remain abreast & aware of applicable training/SOPs/processes required for the conduct of clinical operations/related activities within defined timelines.
  • Ensures that the clinical study / trials are conducted within committed targets and timelines (including fiscal) from study planning through to study completion & archiving.
  • Supports/ Mentors assigned CRA study on-boarding/training, including study site handover oversight & monitors study site progress with CRA.
  • Represents the country at the regional CTT (Clinical Trial Team) and local MT (monitoring team) and is the main contact for the Regional Trial Manager (RTM) or Clinical Trial Operations Manager (CTOM) &/ Trial Supply Operations Manager (TSOM).
  • Ensures collaboration with other CTT and local extended Study Management Team members/stakeholders (e.g., Medical Managers/Advisors, etc), as deemed appropriate with timely & effective information exchange.
  • Consistently demonstrates the skills necessary for effective communication, teamwork, motivating people towards the common study goals & positively influences transversal ways of working within a matrix environment.
  • Investigational Medicinal Product (IMP) Manager: Ensures the IMP process locally.
Clinart MENA
1 year 10 months
2017-12 - 2019-09

feasibility studies

Senior CRA (External) through Clinart MENA
Senior CRA (External) through Clinart MENA
  • Participation in feasibility studies with delegated task from FS responsible; approaching investigators and collects the requested information within the shortest possible timelines in compliance with all terms of confidentiality and current applicable SOPs.
  • Site selection and qualification evaluation.
  • Set-up of a study with regard to submission and approval process and preparation of the documentation as per all applicable local requirements; keep EC and Regulatory authorities informed about study progress and changes.
  • Collect all ECs requirements per allocated studies.
  • Coordination, assistance (if needed) and participation in any trainings and meetings (incl. Investigator Meetings) related to the specific study.
  • Monitoring and quality control of the work of investigational sites; planning and performing monitoring visits in accordance with GCP and the study protocol and guidance.
  • Review and reporting of all protocol deviations/ violations, all AE/ SAEs to sponsor and taking the responsibility for accurate performing of SDV process, ensures proper transferring of CRF data to DM.
  • Reporting of trial progress to the client by writing reports and collecting trial specific data, keeping correspondence, participating in project meetings and teleconferences.
  • Ensuring the study is conducted in accordance with international and national regulatory requirements, Protocol, and applicable Quality Document (SOPs, WI, Plan, Manual, etc).
  • Organization and coordination of investigational products and other study supplies import and accountability as well as export of biological samples. This includes obtaining Import/ Export License (if necessary), contacting the courier company, and coordinating study materials distribution via depot or directly to sites.
  • Providing any requested internal progress reports and completion of the relevant files.
  • Ensuring proper termination and performs any activities related to close out of all study sites and proper finalization of contracted tasks.
  • First line of communication for any study related issues arisen by sites for studies lead by him/ her.
  • Execute any activities in compliance with applicable SOPs, instructions, and principles.
  • Responsible for issues escalation following the proper escalation pathway.
Novartis, Riyadh, Saudi Arabia
2 years 8 months
2015-05 - 2017-12

feasibility studies

CRA
CRA
  • Participation in feasibility studies with delegated task from FS responsible; approaching investigators and collects the requested information within the shortest possible timelines in compliance with all terms of confidentiality and current applicable SOPs.
  • Site selection and qualification evaluation.
  • Set-up of a study with regard to submission and approval process and preparation of the documentation as per all applicable local requirements; keep EC and Regulatory authorities informed about study progress and changes.
  • Collect all ECs requirements per allocated studies.
  • Coordination, assistance (if needed) and participation in any trainings and meetings (incl. Investigator Meetings) related to the specific study.
  • Monitoring and quality control of the work of investigational sites; planning and performing monitoring visits in accordance with GCP and the study protocol and guidance.
  • Review and reporting of all protocol deviations/ violations, all AE/ SAEs to sponsor and taking the responsibility for accurate performing of SDV process, ensures proper transferring of CRF data to DM.
  • Reporting of trial progress to the client by writing reports and collecting trial specific data, keeping correspondence, participating in project meetings and teleconferences.
  • Ensuring the study is conducted in accordance with international and national regulatory requirements, Protocol, and applicable Quality Document (SOPs, WI, Plan, Manual, etc.).
  • Organization and coordination of investigational products and other study supplies import and accountability as well as export of biological samples. This includes obtaining Import/ Export License (if necessary), contacting the courier company, and coordinating study materials distribution via depot or directly to sites.
  • Providing any requested internal progress reports and completion of the relevant files.
  • Ensuring proper termination and performs any activities related to close out of all study sites and proper finalization of contracted tasks.
  • First line of communication for any study related issues arisen by sites for studies lead by him/ her.
  • Execute any activities in compliance with applicable SOPs, instructions, and principles.
  • Responsible for issues escalation following the proper escalation pathway.
Clinart MENA, Riyadh, Saudi Arabia
5 months
2015-01 - 2015-05

research on the animal models (rats) to develop high fat diet induced obesity models

Researcher
Researcher
  • Worked as researcher on the animal models (rats) to develop high fat diet induced obesity models.
  • Handled Laboratory Rats, stored various organs at -80°C for biomarker analysis.
  • Assisted in handling DMT apparatus for muscular reactivity of blood vessel muscles.
King Saud University, Riyadh, Saudi Arabia
1 year 1 month
2013-12 - 2014-12

Cardiovascular Risk Assessment

Clinical Research Coordinator
Clinical Research Coordinator
  • Worked in the program entitled ?Cardiovascular Risk Assessment for King Saud University Employees and Their Families, Developing a framework for an Evidence-Based Cardiovascular Disease Preventive Program?. (Cross-Sectional Study)
  • Worked on ?REFINE-ICD? project on MI patients in collaboration with University of Calgary, Canada, Medtronic, and Boston Scientific.
  • Worked in the study entitled ?Identification of New Cardiac Biomarkers in Heart Failure Patients with Dilated Cardiomyopathies of ischemic etiology?.
  • Worked in the study entitled ?Stroke Prevention in Atrial Fibrillation in Saudi (SPAF-Saudi): A Phase-IV study of Dabigatran Etexilate?.
King Saud University, Riyadh, Saudi Arabia

Aus- und Weiterbildung

Aus- und Weiterbildung

2017 - 2022

MPH, Hamburg University of Applied Sciences, Germany


2006 - 2011

PharmD, University of Sargodha, Sargodha, Pakistan


Training Certificates

2022

Successfully completed onboarding and training package offered by IQVIA for CPMs.


2021-05

Anti-Bribery Anti-Corruption training by TRALIANT


2020-08

GDRP Training by Alison


2020-05

  • TRACE Global Anti-Bribery Compliance Course
  • FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency, Released by USFDA: Mar-2020, Updated on 11-May-2020
  • Guidance on the management of clinical trials during the covid-19 (coronavirus) pandemic, released by EMA: Version 3 dated: 28-Apr-2020


2020-04

  • FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19, Released by USFDA: Mar-2020, Updated on 27-Mar-2020
  • Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic, Released by Saudi FDA: 12-Apr-2020


2020-02

Anti-Bribery Anti-Corruption training by TRALIANT


2019-11

Sanofi Onboarding Training for CPLs: Package offered by Sanofi


2018-02

Novartis Onboarding Training for CRAs: Package offered by Novartis


2017-12

International Health Care Business Integrity for Third Party Intermediaries by Johnson and Johnson


2017-10

ICH GCP (R2) by Pharma school website


2017-07

Supplier Acknowledgement Code of Conduct by TAKEDA


2017-04

Clinical Operation Ongoing training: Central filling process; Patient informed consent process & patient materials; Source documents - verification and monitoring skills; IMP accountability; Communication Skill by Clinart MENA


2017-02

ICH GCP Certificate including addendum by PharmaSchool


2016-10

Clinical Operation Ongoing Training by Clinart MENA


2016-07

Oracle RDC: 4.5.3/4.6: By Quintiles


2016-03

CRA Roles and responsibilities: Chapter by SoCRA


2016-01

Biometric Training Program: by Clinart MENA


2015

On boarding training with Clinart inclusive to the following sessions:

  • Quality Management System
  • Introduction to Research Ethics/ Clinical Trial Overview
  • GCP Overview, Investigator / Sponsor Responsibility
  • SDV and Monitoring Skills
  • Adverse Events and Safety Reporting
  • Patient informed consent process; patient material
  • Audit preparation and CAPA
  • Central filling; Essential document review; Trial Master File


2015

Introduction to time management by Alison web site


2015-08

GCP Training Program by Clinart MENA


2015-06

  • ICF Training: By Clinart MENA
  • GCP: Essential guidelines and legislation: by PharmaSchool


2014-03

Oracle: Inf 4.6 CRC Modules


Professional Exams

2012-04

Graduation Assessment Test-(GAT)-General (NTS-Pak)


2012-11

Saudi Licensing Examination-(SLE)-Prometric (KSA)


Certifications

2012 till present

Registered Pharmacist, Punjab Pharmacy Council, Pakistan


2013 till present

Registered Pharmacist, Saudi Council for Health Specialties

Position

Position

I have more than 9 years of clinical research experience, with around 3.5 years as Clinical Project Manager (Hybrid role with Clinical Trial Manager), 2 years as Senior CRA (Novartis), 2.5 years as CRA (CTI) and 1.5 years as CRC. I have actively worked with over 10 CRAs/ Sn. CRAs involved in different phases of clinical trials including Interventional Trials (Phase II, III, IV) and Non-Interventional Studies with wide range of therapeutic areas in Drug Development and Medical Devices. Countries I worked currently include Europe, and Backup Role for USA, Canada, and Brazil, whereas previously I worked for Saudi Arabia, Dubai, Jordan, Pakistan.

Currently, I am looking for promising, permanent position in a CRO or Pharmaceutical company that offers work-life balanced opportunity in Germany. I have a Blue Card, Valid for 4 years (Sep-2026).


Below are the positions that I am currently targeting;

  • Clinical Project Lead/Manager
  • Clinical Research Lead/Manager
  • Clinical Team Lead/Manager
  • Clinical Study Lead/ Manager
  • Clinical Operations Lead/ Manager

Kompetenzen

Kompetenzen

Top-Skills

Good Clinical Practice Clinical Research Clinical Project

Produkte / Standards / Erfahrungen / Methoden

Profile

  • I have more than 9 years of clinical research experience, with around 3.5 years as Clinical Project Manager (Hybrid role with Clinical Trial Manager), 2 years as Senior CRA (Novartis), 2.5 years as CRA (CTI) and 1.5 years as CRC. I have actively worked with over 10 CRAs/ Sn. CRAs involved in different phases of clinical trials including Interventional Trials (Phase II, III, IV) and Non-Interventional Studies with wide range of therapeutic areas in Drug Development and Medical Devices. Countries I worked currently include Europe, and Backup Role for USA, Canada, and Brazil, whereas previously I worked for Saudi Arabia, Dubai, Jordan, Pakistan.
  • Currently, I am looking for promising, permanent position in a CRO or Pharmaceutical company that offers work-life balanced opportunity in Germany. I have a Blue Card, Valid for 4 years (Sep-2026)


My experience involves

  • Project Timelines and Deliverables Management including but not limited to: site and country feasibilities and careful selection of potential sites, PSVs, Investigator Meetings, SIVs, developing/implementing patient recruitment and retention policies, SMVs, Remote SMVs, Co-MVs, COVs, TMF setup, maintenance & QC/audit checks till archiving.
  • Strictly working in compliance with study protocol and according to applicable SOPs, ICH GCP guidelines, applicable local and international policies & regulations.
  • Continuous communications and follow ups with clinical/regulatory teams to ensure on-time submission of IRB/EC & Regulatory Documents (clinical trials application dossiers), responding to any queries from applicable authorities till final approval is received.
  • Participation in Study budget estimations, supervising site contracts (with PI, pharmacy, Lab, etc.) with contracts team & ensuring timely site payments according to agreed contracts.
  • Surveillance on Safety reporting requirements (AEs, SAEs, ADR, ADE, SADE, SUSARs, DSUR, PSUR etc.).
  • Working on Risk Identification and Risk Management Plans.
  • Management of Protocol Deviations, CAPA implementation/ mitigation plans and makes the site and countries Audit/Inspection ready. Successfully completed number IRB/EC Audits, SFDA inspection at site and country levels with only 2-5 minor findings, 1-2 major findings and without any critical findings.
  • Multi Country Vendors Management including but not limited to; translations, regulatory submissions/approvals, coordinating/tracking Biomarker samples/IMP/Devices and ancillary shipments/returns to ensure timely and uninterrupted normal/cold supplies to clinical trial sites; and dealing with IVRS/IWRS for randomizations, keeping study blinds and acting as backup randomizer.
  • Interdepartmental collaborative meetings on regular basis and leading cross function teams including but not limited to; Medical, Quality, Regulatory, Safety, Data Management, Legal, Finance, within company as well with other vendors & CROs.
  • Working closely with Clinical Monitoring Team (CTAs, CRAs, Sn CRAs, CTMs) in terms of regular follow up meetings on study progress at site levels, review/approval of monitoring reports, performing Co-MVs if needed.
  • Responsible for resources allocations in terms of work load, regular time sheet analysis, training allocation & support/guidance provision to team when needed; and performance evaluation at ongoing basis.
  • Assistance to Medical Writing team in review of clinical study protocol, all study related plans (management plans, monitoring plans, risk management plan, safety plan, data management plan, data validation plan etc.), Informed consents/patient facing documents.


Therapeutic Experience

Around 9-year experience in clinical research including phase II, III, IV trials, Product Registries, Disease Registries, Observational studies

  • Endocrinology: Diabetology - Congenital Hyperinsulinism (Phase II)
  • Endocrinology: Diabetology ? Type 2 DM (Phase III, RCT, Double Blind, Placebo Control)
  • Endocrinology: Diabetology ? Type 2 DM (Phase III, RCT, Open Label)
  • Hematology: Pediatric ? Sickle Cell Disease (Phase III, RCT, Double Blind, Placebo Control)
  • Oncology: Breast Cancer ? Breast Cancer (Phase III, Open Label)
  • Hematology: Blood Coagulation Disorders ? Thrombocytopenia (Phase III, Open Label)
  • Hematology: Coagulation Disorders ? Hemophilia (Phase III, Open Label)
  • Hematology: Coagulation Disorders ? Congenital Fibrinogen Deficiency (Phase III, Open Label)
  • Infectious Diseases: Immunology ? Genital Warts (Phase III, RCT, Double Blind, Placebo Control)
  • Infectious Diseases: Virology ? MERS (Phase III, RCT, Double Blind, Placebo Control)
  • Infectious Diseases: Critical Care ? VAP (Phase III, RCT, Double Blind, Placebo Control)
  • Ophthalmology: Ophthalmology ? Uveitic Macular Edema (Phase III b, Open Label)
  • Internal Medicine: Gastroenterology ? IBS (Phase IV, RCT, Double Blind, Placebo Control)
  • Genetics: Immunology ? PIDD (Phase IV, Open Label)
  • Dermatology: Adult Infectious Diseases ? Dermatitis with Fungus (Phase IV, Open Label)
  • Dermatology: Pediatric Infectious Diseases ? Dermatitis with Fungus (Phase IV, Open Label)
  • Ophthalmology: Infectious Diseases ? Bacterial Conjunctivitis (Phase IV, Open Label)
  • Ophthalmology: Immunology ? Chronic Allergic Conjunctivitis (Phase IV, Open Label)
  • Internal Medicine: Pulmonology ? Asthma (Phase IV, RCT, Double Blind, Placebo Control)
  • Endocrinology: Diabetology ? T2DM (Ramadan Only Study) (Product Registry)
  • Endocrinology: Diabetology ? T2DM (One Year Study, Cohort) (Product Registry)
  • Oncology: Immuno-Oncology ? Colorectal Cancer (Disease Registry)
  • Internal Medicine: Cardiology ? Heart Failure (Disease Registry)
  • Rare Diseases: Cardiology ? Hypertrophic Cardiomyopathies (Diagnostic Study)
  • Rare Diseases: Nephrology ? Chronic Kidney Disease (Diagnostic Study)
  • Radiology: Cardiology/Angioplasty ? DEB vs BES/BM (Single Blind RCT, Device Trial)
  • Radiology: Neurology/Stroke ? Distal Ischemic Stroke, Open label (Device Trial)


Experience on Systems:

  • Excellent Command on MS Offices (Word, Excel, PowerPoint, OneNote)
  • CTMS (ClubNet, IMPACT,gnosuss)
  • eCRF (Oracle RDC, Viedoc, Linical, Rave, RaveX, Datatrak, IL2, EDC)
  • IRT (Clinphone, Theradex, Calyx, Almac)
  • eTMF (g-drive, CTP, Veeva Vault Clinical, Wingspan)

Einsatzorte

Einsatzorte

Deutschland
möglich

Projekte

Projekte

7 months
2022-10 - 2023-04

delivery and management of clinical studies

Clinical Project (Trial) Manager
Clinical Project (Trial) Manager
  • Responsible for delivery and management of clinical studies, including multiple and full service, and multi-regional studies.
  • Develop integrated study management plans with the core project team.
  • Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies, and procedures.
  • Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy, and approach, effectively communicate, and assess performance.
  • Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
  • Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally.
  • Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
  • Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
  • May serve as primary or backup project contact with customer and would then own the relationship with the project?s key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.
  • Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.
  • Ensure the financial success of the project.
  • Forecast and identify opportunities to accelerate activities to bring revenue forward.
  • Identify changes in scope and manage change control process as necessary.
  • Identify lessons learned and implement best practices.
  • May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.
  • Adopt corporate initiatives and changes and serve as a change advocate when necessary.
  • Provide input to line managers of their project team members? performance relative to project tasks.
  • Support staff development and mentor less experienced project team members on assigned projects to support their professional development.
  • Participate in bid defense presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
IQVIA RDS GmbH, Bremen, Germany
Bremen
8 months
2021-10 - 2022-05

Coordination and control over the feasibility, start-up, clinical and site-management activities

Clinical Project Lead
Clinical Project Lead
  • Coordination and control over the feasibility, start-up, clinical and site-management activities related to a specific clinical trial within the Department;
  • Strict control over the compliance of study milestones: start, patients? enrolment (overall study) and timelines as per the contract obligations.
  • Control over budget, issue, task, and time management of the project/s under his/her supervision.
  • Communication with sponsors, partnering CROs, physicians, or regulatory authorities.
  • Manage the process of creation, approval all essential documents developed or tailored in-house as ICF, Patients Material, translated documents.
  • Responsible for distribution within the team of final approved version of all essential documents (Protocol, IB, CRF, ICF, etc.).
  • Initiate selection and approval, ongoing management and dealing with all third parties involved in the study.
  • Control over all logistic procedures related to the study.
  • Identify changes, work with team members to quantify financial / time impact and communicate those changes to appropriate personnel.
  • Assisting Dir. FND in contracting process, when required.
  • Control of submission/ approval process to EC/ RA in close collaboration with the clinical research associates.
  • Organization and performing of study team trainings, meetings, and customization of study-specific forms.
  • Develop and distribute to the team any study-specific manuals, instructions, and guidelines.
  • Ensure timely reports? review.
  • Coordinate activities between different stakeholders and determine interim study time points.
  • Providing any requested internal progress reports and completion of the relevant files.
  • Preparation and conducting of Investigator Meetings in close collaboration with Financial Dept.
  • Collaboration with internal/ external auditors, co-monitors, or regulatory inspectors in review of files and patient data.
  • Management of Third parties on study level for any subcontracting or external lab.
  • Execute any activities in compliance with applicable SOPs, instructions, and principles.
  • Develop Study Specific plans as PMP, monitoring plan, TMF maintenance plan, communication plan, quality plan, project risk matrix (if applicable).
  • Perform SCRA activities as per assigned clinical trials.
CTI Clinical Trial and Consulting Services, Inc., Riyadh, Saudi Arabia
1 year 9 months
2020-01 - 2021-09

plan, coordinate execution and accomplish clinical projects

Clinical Project Lead
Clinical Project Lead
  • To plan, coordinate execution and accomplish clinical projects under his/her responsibility in accordance with ICH GCP, applicable global & local SOPs, local regulations, ethics/compliance, and clinical practice.
  • Is accountable for coordination of study activities generated by clinical trial/studies, in compliance with the company quality standards and the regulations in force, the forecasted timelines, milestones and study budget.
  • Works closely with COM/key stakeholders and is responsible for the planning, set-up, progress & delivery, close/archiving through to eventual reporting of a clinical trial/study within the country.
  • Takes measures to ensure study conduct ultimately protects the rights and well-being of participating patients/subjects & trial data integrity and credibility.
  • Takes ownership and accountability to remain abreast & aware of applicable training/SOPs/processes required for the conduct of clinical operations/related activities within defined timelines.
  • Ensures that the clinical study / trials are conducted within committed targets and timelines (including fiscal) from study planning through to study completion & archiving.
  • Supports/ Mentors assigned CRA study on-boarding/training, including study site handover oversight & monitors study site progress with CRA.
  • Represents the country at the regional CTT (Clinical Trial Team) and local MT (monitoring team) and is the main contact for the Regional Trial Manager (RTM) or Clinical Trial Operations Manager (CTOM) &/ Trial Supply Operations Manager (TSOM).
  • Ensures collaboration with other CTT and local extended Study Management Team members/stakeholders (e.g., Medical Managers/Advisors, etc), as deemed appropriate with timely & effective information exchange.
  • Consistently demonstrates the skills necessary for effective communication, teamwork, motivating people towards the common study goals & positively influences transversal ways of working within a matrix environment.
  • Investigational Medicinal Product (IMP) Manager: Ensures the IMP process locally.
COVANCE Inc./RAY Alliance
4 months
2019-09 - 2019-12

plan, coordinate execution and accomplish clinical projects

Clinical Project Lead
Clinical Project Lead
  • To plan, coordinate execution and accomplish clinical projects under his/her responsibility in accordance with ICH GCP, applicable global & local SOPs, local regulations, ethics/compliance, and clinical practice.
  • Is accountable for coordination of study activities generated by clinical trial/studies, in compliance with the company quality standards and the regulations in force, the forecasted timelines, milestones and study budget.
  • Works closely with COM/key stakeholders and is responsible for the planning, set-up, progress & delivery, close/archiving through to eventual reporting of a clinical trial/study within the country.
  • Takes measures to ensure study conduct ultimately protects the rights and well-being of participating patients/subjects & trial data integrity and credibility.
  • Takes ownership and accountability to remain abreast & aware of applicable training/SOPs/processes required for the conduct of clinical operations/related activities within defined timelines.
  • Ensures that the clinical study / trials are conducted within committed targets and timelines (including fiscal) from study planning through to study completion & archiving.
  • Supports/ Mentors assigned CRA study on-boarding/training, including study site handover oversight & monitors study site progress with CRA.
  • Represents the country at the regional CTT (Clinical Trial Team) and local MT (monitoring team) and is the main contact for the Regional Trial Manager (RTM) or Clinical Trial Operations Manager (CTOM) &/ Trial Supply Operations Manager (TSOM).
  • Ensures collaboration with other CTT and local extended Study Management Team members/stakeholders (e.g., Medical Managers/Advisors, etc), as deemed appropriate with timely & effective information exchange.
  • Consistently demonstrates the skills necessary for effective communication, teamwork, motivating people towards the common study goals & positively influences transversal ways of working within a matrix environment.
  • Investigational Medicinal Product (IMP) Manager: Ensures the IMP process locally.
Clinart MENA
1 year 10 months
2017-12 - 2019-09

feasibility studies

Senior CRA (External) through Clinart MENA
Senior CRA (External) through Clinart MENA
  • Participation in feasibility studies with delegated task from FS responsible; approaching investigators and collects the requested information within the shortest possible timelines in compliance with all terms of confidentiality and current applicable SOPs.
  • Site selection and qualification evaluation.
  • Set-up of a study with regard to submission and approval process and preparation of the documentation as per all applicable local requirements; keep EC and Regulatory authorities informed about study progress and changes.
  • Collect all ECs requirements per allocated studies.
  • Coordination, assistance (if needed) and participation in any trainings and meetings (incl. Investigator Meetings) related to the specific study.
  • Monitoring and quality control of the work of investigational sites; planning and performing monitoring visits in accordance with GCP and the study protocol and guidance.
  • Review and reporting of all protocol deviations/ violations, all AE/ SAEs to sponsor and taking the responsibility for accurate performing of SDV process, ensures proper transferring of CRF data to DM.
  • Reporting of trial progress to the client by writing reports and collecting trial specific data, keeping correspondence, participating in project meetings and teleconferences.
  • Ensuring the study is conducted in accordance with international and national regulatory requirements, Protocol, and applicable Quality Document (SOPs, WI, Plan, Manual, etc).
  • Organization and coordination of investigational products and other study supplies import and accountability as well as export of biological samples. This includes obtaining Import/ Export License (if necessary), contacting the courier company, and coordinating study materials distribution via depot or directly to sites.
  • Providing any requested internal progress reports and completion of the relevant files.
  • Ensuring proper termination and performs any activities related to close out of all study sites and proper finalization of contracted tasks.
  • First line of communication for any study related issues arisen by sites for studies lead by him/ her.
  • Execute any activities in compliance with applicable SOPs, instructions, and principles.
  • Responsible for issues escalation following the proper escalation pathway.
Novartis, Riyadh, Saudi Arabia
2 years 8 months
2015-05 - 2017-12

feasibility studies

CRA
CRA
  • Participation in feasibility studies with delegated task from FS responsible; approaching investigators and collects the requested information within the shortest possible timelines in compliance with all terms of confidentiality and current applicable SOPs.
  • Site selection and qualification evaluation.
  • Set-up of a study with regard to submission and approval process and preparation of the documentation as per all applicable local requirements; keep EC and Regulatory authorities informed about study progress and changes.
  • Collect all ECs requirements per allocated studies.
  • Coordination, assistance (if needed) and participation in any trainings and meetings (incl. Investigator Meetings) related to the specific study.
  • Monitoring and quality control of the work of investigational sites; planning and performing monitoring visits in accordance with GCP and the study protocol and guidance.
  • Review and reporting of all protocol deviations/ violations, all AE/ SAEs to sponsor and taking the responsibility for accurate performing of SDV process, ensures proper transferring of CRF data to DM.
  • Reporting of trial progress to the client by writing reports and collecting trial specific data, keeping correspondence, participating in project meetings and teleconferences.
  • Ensuring the study is conducted in accordance with international and national regulatory requirements, Protocol, and applicable Quality Document (SOPs, WI, Plan, Manual, etc.).
  • Organization and coordination of investigational products and other study supplies import and accountability as well as export of biological samples. This includes obtaining Import/ Export License (if necessary), contacting the courier company, and coordinating study materials distribution via depot or directly to sites.
  • Providing any requested internal progress reports and completion of the relevant files.
  • Ensuring proper termination and performs any activities related to close out of all study sites and proper finalization of contracted tasks.
  • First line of communication for any study related issues arisen by sites for studies lead by him/ her.
  • Execute any activities in compliance with applicable SOPs, instructions, and principles.
  • Responsible for issues escalation following the proper escalation pathway.
Clinart MENA, Riyadh, Saudi Arabia
5 months
2015-01 - 2015-05

research on the animal models (rats) to develop high fat diet induced obesity models

Researcher
Researcher
  • Worked as researcher on the animal models (rats) to develop high fat diet induced obesity models.
  • Handled Laboratory Rats, stored various organs at -80°C for biomarker analysis.
  • Assisted in handling DMT apparatus for muscular reactivity of blood vessel muscles.
King Saud University, Riyadh, Saudi Arabia
1 year 1 month
2013-12 - 2014-12

Cardiovascular Risk Assessment

Clinical Research Coordinator
Clinical Research Coordinator
  • Worked in the program entitled ?Cardiovascular Risk Assessment for King Saud University Employees and Their Families, Developing a framework for an Evidence-Based Cardiovascular Disease Preventive Program?. (Cross-Sectional Study)
  • Worked on ?REFINE-ICD? project on MI patients in collaboration with University of Calgary, Canada, Medtronic, and Boston Scientific.
  • Worked in the study entitled ?Identification of New Cardiac Biomarkers in Heart Failure Patients with Dilated Cardiomyopathies of ischemic etiology?.
  • Worked in the study entitled ?Stroke Prevention in Atrial Fibrillation in Saudi (SPAF-Saudi): A Phase-IV study of Dabigatran Etexilate?.
King Saud University, Riyadh, Saudi Arabia

Aus- und Weiterbildung

Aus- und Weiterbildung

2017 - 2022

MPH, Hamburg University of Applied Sciences, Germany


2006 - 2011

PharmD, University of Sargodha, Sargodha, Pakistan


Training Certificates

2022

Successfully completed onboarding and training package offered by IQVIA for CPMs.


2021-05

Anti-Bribery Anti-Corruption training by TRALIANT


2020-08

GDRP Training by Alison


2020-05

  • TRACE Global Anti-Bribery Compliance Course
  • FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency, Released by USFDA: Mar-2020, Updated on 11-May-2020
  • Guidance on the management of clinical trials during the covid-19 (coronavirus) pandemic, released by EMA: Version 3 dated: 28-Apr-2020


2020-04

  • FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19, Released by USFDA: Mar-2020, Updated on 27-Mar-2020
  • Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic, Released by Saudi FDA: 12-Apr-2020


2020-02

Anti-Bribery Anti-Corruption training by TRALIANT


2019-11

Sanofi Onboarding Training for CPLs: Package offered by Sanofi


2018-02

Novartis Onboarding Training for CRAs: Package offered by Novartis


2017-12

International Health Care Business Integrity for Third Party Intermediaries by Johnson and Johnson


2017-10

ICH GCP (R2) by Pharma school website


2017-07

Supplier Acknowledgement Code of Conduct by TAKEDA


2017-04

Clinical Operation Ongoing training: Central filling process; Patient informed consent process & patient materials; Source documents - verification and monitoring skills; IMP accountability; Communication Skill by Clinart MENA


2017-02

ICH GCP Certificate including addendum by PharmaSchool


2016-10

Clinical Operation Ongoing Training by Clinart MENA


2016-07

Oracle RDC: 4.5.3/4.6: By Quintiles


2016-03

CRA Roles and responsibilities: Chapter by SoCRA


2016-01

Biometric Training Program: by Clinart MENA


2015

On boarding training with Clinart inclusive to the following sessions:

  • Quality Management System
  • Introduction to Research Ethics/ Clinical Trial Overview
  • GCP Overview, Investigator / Sponsor Responsibility
  • SDV and Monitoring Skills
  • Adverse Events and Safety Reporting
  • Patient informed consent process; patient material
  • Audit preparation and CAPA
  • Central filling; Essential document review; Trial Master File


2015

Introduction to time management by Alison web site


2015-08

GCP Training Program by Clinart MENA


2015-06

  • ICF Training: By Clinart MENA
  • GCP: Essential guidelines and legislation: by PharmaSchool


2014-03

Oracle: Inf 4.6 CRC Modules


Professional Exams

2012-04

Graduation Assessment Test-(GAT)-General (NTS-Pak)


2012-11

Saudi Licensing Examination-(SLE)-Prometric (KSA)


Certifications

2012 till present

Registered Pharmacist, Punjab Pharmacy Council, Pakistan


2013 till present

Registered Pharmacist, Saudi Council for Health Specialties

Position

Position

I have more than 9 years of clinical research experience, with around 3.5 years as Clinical Project Manager (Hybrid role with Clinical Trial Manager), 2 years as Senior CRA (Novartis), 2.5 years as CRA (CTI) and 1.5 years as CRC. I have actively worked with over 10 CRAs/ Sn. CRAs involved in different phases of clinical trials including Interventional Trials (Phase II, III, IV) and Non-Interventional Studies with wide range of therapeutic areas in Drug Development and Medical Devices. Countries I worked currently include Europe, and Backup Role for USA, Canada, and Brazil, whereas previously I worked for Saudi Arabia, Dubai, Jordan, Pakistan.

Currently, I am looking for promising, permanent position in a CRO or Pharmaceutical company that offers work-life balanced opportunity in Germany. I have a Blue Card, Valid for 4 years (Sep-2026).


Below are the positions that I am currently targeting;

  • Clinical Project Lead/Manager
  • Clinical Research Lead/Manager
  • Clinical Team Lead/Manager
  • Clinical Study Lead/ Manager
  • Clinical Operations Lead/ Manager

Kompetenzen

Kompetenzen

Top-Skills

Good Clinical Practice Clinical Research Clinical Project

Produkte / Standards / Erfahrungen / Methoden

Profile

  • I have more than 9 years of clinical research experience, with around 3.5 years as Clinical Project Manager (Hybrid role with Clinical Trial Manager), 2 years as Senior CRA (Novartis), 2.5 years as CRA (CTI) and 1.5 years as CRC. I have actively worked with over 10 CRAs/ Sn. CRAs involved in different phases of clinical trials including Interventional Trials (Phase II, III, IV) and Non-Interventional Studies with wide range of therapeutic areas in Drug Development and Medical Devices. Countries I worked currently include Europe, and Backup Role for USA, Canada, and Brazil, whereas previously I worked for Saudi Arabia, Dubai, Jordan, Pakistan.
  • Currently, I am looking for promising, permanent position in a CRO or Pharmaceutical company that offers work-life balanced opportunity in Germany. I have a Blue Card, Valid for 4 years (Sep-2026)


My experience involves

  • Project Timelines and Deliverables Management including but not limited to: site and country feasibilities and careful selection of potential sites, PSVs, Investigator Meetings, SIVs, developing/implementing patient recruitment and retention policies, SMVs, Remote SMVs, Co-MVs, COVs, TMF setup, maintenance & QC/audit checks till archiving.
  • Strictly working in compliance with study protocol and according to applicable SOPs, ICH GCP guidelines, applicable local and international policies & regulations.
  • Continuous communications and follow ups with clinical/regulatory teams to ensure on-time submission of IRB/EC & Regulatory Documents (clinical trials application dossiers), responding to any queries from applicable authorities till final approval is received.
  • Participation in Study budget estimations, supervising site contracts (with PI, pharmacy, Lab, etc.) with contracts team & ensuring timely site payments according to agreed contracts.
  • Surveillance on Safety reporting requirements (AEs, SAEs, ADR, ADE, SADE, SUSARs, DSUR, PSUR etc.).
  • Working on Risk Identification and Risk Management Plans.
  • Management of Protocol Deviations, CAPA implementation/ mitigation plans and makes the site and countries Audit/Inspection ready. Successfully completed number IRB/EC Audits, SFDA inspection at site and country levels with only 2-5 minor findings, 1-2 major findings and without any critical findings.
  • Multi Country Vendors Management including but not limited to; translations, regulatory submissions/approvals, coordinating/tracking Biomarker samples/IMP/Devices and ancillary shipments/returns to ensure timely and uninterrupted normal/cold supplies to clinical trial sites; and dealing with IVRS/IWRS for randomizations, keeping study blinds and acting as backup randomizer.
  • Interdepartmental collaborative meetings on regular basis and leading cross function teams including but not limited to; Medical, Quality, Regulatory, Safety, Data Management, Legal, Finance, within company as well with other vendors & CROs.
  • Working closely with Clinical Monitoring Team (CTAs, CRAs, Sn CRAs, CTMs) in terms of regular follow up meetings on study progress at site levels, review/approval of monitoring reports, performing Co-MVs if needed.
  • Responsible for resources allocations in terms of work load, regular time sheet analysis, training allocation & support/guidance provision to team when needed; and performance evaluation at ongoing basis.
  • Assistance to Medical Writing team in review of clinical study protocol, all study related plans (management plans, monitoring plans, risk management plan, safety plan, data management plan, data validation plan etc.), Informed consents/patient facing documents.


Therapeutic Experience

Around 9-year experience in clinical research including phase II, III, IV trials, Product Registries, Disease Registries, Observational studies

  • Endocrinology: Diabetology - Congenital Hyperinsulinism (Phase II)
  • Endocrinology: Diabetology ? Type 2 DM (Phase III, RCT, Double Blind, Placebo Control)
  • Endocrinology: Diabetology ? Type 2 DM (Phase III, RCT, Open Label)
  • Hematology: Pediatric ? Sickle Cell Disease (Phase III, RCT, Double Blind, Placebo Control)
  • Oncology: Breast Cancer ? Breast Cancer (Phase III, Open Label)
  • Hematology: Blood Coagulation Disorders ? Thrombocytopenia (Phase III, Open Label)
  • Hematology: Coagulation Disorders ? Hemophilia (Phase III, Open Label)
  • Hematology: Coagulation Disorders ? Congenital Fibrinogen Deficiency (Phase III, Open Label)
  • Infectious Diseases: Immunology ? Genital Warts (Phase III, RCT, Double Blind, Placebo Control)
  • Infectious Diseases: Virology ? MERS (Phase III, RCT, Double Blind, Placebo Control)
  • Infectious Diseases: Critical Care ? VAP (Phase III, RCT, Double Blind, Placebo Control)
  • Ophthalmology: Ophthalmology ? Uveitic Macular Edema (Phase III b, Open Label)
  • Internal Medicine: Gastroenterology ? IBS (Phase IV, RCT, Double Blind, Placebo Control)
  • Genetics: Immunology ? PIDD (Phase IV, Open Label)
  • Dermatology: Adult Infectious Diseases ? Dermatitis with Fungus (Phase IV, Open Label)
  • Dermatology: Pediatric Infectious Diseases ? Dermatitis with Fungus (Phase IV, Open Label)
  • Ophthalmology: Infectious Diseases ? Bacterial Conjunctivitis (Phase IV, Open Label)
  • Ophthalmology: Immunology ? Chronic Allergic Conjunctivitis (Phase IV, Open Label)
  • Internal Medicine: Pulmonology ? Asthma (Phase IV, RCT, Double Blind, Placebo Control)
  • Endocrinology: Diabetology ? T2DM (Ramadan Only Study) (Product Registry)
  • Endocrinology: Diabetology ? T2DM (One Year Study, Cohort) (Product Registry)
  • Oncology: Immuno-Oncology ? Colorectal Cancer (Disease Registry)
  • Internal Medicine: Cardiology ? Heart Failure (Disease Registry)
  • Rare Diseases: Cardiology ? Hypertrophic Cardiomyopathies (Diagnostic Study)
  • Rare Diseases: Nephrology ? Chronic Kidney Disease (Diagnostic Study)
  • Radiology: Cardiology/Angioplasty ? DEB vs BES/BM (Single Blind RCT, Device Trial)
  • Radiology: Neurology/Stroke ? Distal Ischemic Stroke, Open label (Device Trial)


Experience on Systems:

  • Excellent Command on MS Offices (Word, Excel, PowerPoint, OneNote)
  • CTMS (ClubNet, IMPACT,gnosuss)
  • eCRF (Oracle RDC, Viedoc, Linical, Rave, RaveX, Datatrak, IL2, EDC)
  • IRT (Clinphone, Theradex, Calyx, Almac)
  • eTMF (g-drive, CTP, Veeva Vault Clinical, Wingspan)

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