Seasoned Freelanced M.Sc. Clinical Research of Global Clinical Trials: 20+ Years Mastering all Phases, multiple Indications, quality risk management
Aktualisiert am 10.06.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 07.06.2024
Verfügbar zu: 100%
davon vor Ort: 100%
Clinical Research
Study Management
Clinical Study Services
KOL-Management
Budget Management
Outsourcing
EDC
ICH-GCP
Site-Management
Line Management
Matrix Managment
Resilience
Strong Communication Skills
Pharmaceutical Knowledge
Local
Regional
Global
Biopharmaceutical Knowledge
All Phases
Supervision
CTMS
German
native
English
fluent
French
basic

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

3 Monate
2024-01 - 2024-03

Diff. Indications

  • Diff. Indications, diff. companies (Freelanced, GER, CH)
  • Study management ? special tasks
  • communication ECs/HAs/IRBs
2 Jahre 10 Monate
2021-03 - 2023-12

Study management

Global Senior Clinical Manager
Global Senior Clinical Manager
Oncology, Immuno-Oncology 
  • Study management - all activities (planning, performance, completion)
  • ensuring target KPIs met; KOL management
  • line/budget/vendor management
  • ensuring quality, budget, timelines
  • reporting (status, ad  hoc etc)
  • development study strategies, study outlines
  • communication ECs/HAs/IRBs etc.

Oncology, Immuno-Oncology
1 Jahr
2020-03 - 2021-02

Various projects

Reviewer Clinical Protocol/Study Documents
Reviewer Clinical Protocol/Study Documents
  • Oncology ? Haematology, Solid Tumours (diff. companies CH, GER, A)
4 Monate
2019-11 - 2020-02

Study Start up activities

Senior Clinical Project Manager
Senior Clinical Project Manager
Oncology - Haematology, Solid Tumours (Skin), Rare diseases
  • Study Start up activities
  • communication with ECs/HAs/IRBs
  • study management overall, milestones, budget, staff and beyond

Takeda AG CH
7 Monate
2019-04 - 2019-10

Study management overal

Senior Clinical Project Manager
Senior Clinical Project Manager
Oncology ? Solid Tumours (Skin) (Global)
  • Study Start up activities
  • communication with ECs/HAs/IRBs
  • study management overall, milestones, budget, staff and beyond

4 Monate
2019-01 - 2019-04

Start Up/Study Management

Senior Clinical Research Manager
Senior Clinical Research Manager
Virology/Tumour Vaccines (IMA CH)
  • Start Up/Study Management - all responsibilities as described below

1 Jahr 9 Monate
2017-04 - 2018-12

Reviewer Clinical Protocol/Study Documents

Oncology ? Haematology, Solid Tumours (Freelanced; IMA, CH)
  • Protocol review
  • synopsis
  • communication ECs/HAs/IRBs
  • development amendments, IBs, PICs, CRFs, study manuals, study tools (feasibility questionnaires, site qualification documents, patient diaries)
  • compilation IMPD, submission packages, submission
  • creating information material (marketing/non-marketing)
  • close collaboration with KOLs
  • consultancy operational items etc
1 Jahr
2016-04 - 2017-03

Study management - all activities

Clinical Research Manager
Clinical Research Manager
Ovarian Cancer (Astellas GER), Team Lead
  • Study management - all activities (planning, performance, completion)
  • ensuring target KPIs met; KOL management
  • line, budget, vendor management
  • ensuring targets met (quality, budget, timelines); reporting (status reports, ad hoc reports)
  • development study strategies, study outlines
  • consultancy Due Diligence
  • communication ECs/HAs/IRBs etc.

1 Jahr 4 Monate
2015-04 - 2016-07

Reviewer Clinical Protocol/Study Documents

Oncology ? Haematology, Solid Tumours (Melanoma, Basal Cell Carcinoma), Onco-Immunology, MS, Virology/Vaccines (diff. companies CH)
  • Protocol review
  • synopsis
  • communication ECs/HAs/IRBs
  • development amendments, IBs, PICs, ICFs, CRFs, study manuals, study tools (feasibility questionnaires, site qualification documents, patient diaries)
  • compilation IMPD
  • submission packages
  • submissions
  • creating information material (non-marketing/ marketing)
  • consultancy KOLs and operational items etc.

2 Jahre
2013-04 - 2015-03

CRA management

Senior Clinical Project Manager, Team Lead
Senior Clinical Project Manager, Team Lead
Oncology - Haematology, Solid Tumours (Derma-Oncology), Rare diseases, Virology/Vaccines, Onco-Immunology 
  • Study management - all activities (planning, conduct, completion)
  • feasibility, forecasts
  • site selection
  • tracking site performance, enrolment
  • CRA management
  • budget, line vendor management
  • ensuring KPIs met (quality, budget, timelines)
  • identifying areas of concern
  • adherence to all relevant guidelines and regulations
  • establish robust relationships with institutions and KOL management
  • ensuring inspection readiness
  • development strategies
  • study outline
  • reporting (status reports, ad hoc reports)
  • communication ECs/HAs/IRBs
  • submission package
  • submissions
  • communication to all stakeholders as Medical Advisor with regard to upcoming questions to IMP, specific study protocols
  • Medical information services requests from PIs, site staff, internal/external stakeholders
Novartis CH
3 Monate
2013-01 - 2013-03

Submission packages

Regulatory Affairs Manager
Regulatory Affairs Manager
Oncology - Haematology, Solid Tumours (Derma-Oncology), Onco-Immunology; Rare diseases 
  • Submission packages
  • submissions
  • cross-functional cooperation with QA, Marketing
  • consultancy study program approach
  • compilation IMPD
  • supervision of all quality aspects of participating sites and qualification of relevant site staff; strategic input
  • Module 2
  • cooperation, communication ECs/HAs/IRBs etc

Novartis CH
10 Monate
2012-03 - 2012-12

Budget, line and vendor management

Senior Clinical Project Manager/Medical Advisor Oncology , Team Lead
Senior Clinical Project Manager/Medical Advisor Oncology , Team Lead
Oncology - Haematology, Solid Tumours (Derma-Oncology), Onco-Immunology, MS, Rare diseases 
  • Study management - all activities (planning, performance, completion)
  • feasibility, decision selection of sites
  • permanent control of site performance, enrolment numbers
  • strong communication with all stakeholders internal and external
  • budget, line and vendor management
  • ensuring targets met (quality, budget, timelines, DB freeze)
  • ensuring inspection readiness
  • adherence to all relevant guidelines and regulations
  • KOL management, institutions and all relevant stakeholders
  • development strategies
  • study outlines, status reports
  • communication ECs/HAs/IRBs
  • communication to all stakeholders as Medical Advisor with regard to upcoming questions to IMP, specific study protocols;
  • Medical information services requests from PIs, site staff, internal/external stakeholders etc.
Novartis CH
1 Jahr 4 Monate
2010-11 - 2012-02

Planning, tactics and strategies

Country Study Manager, Team Lead
Country Study Manager, Team Lead
Oncology, Virology/Vaccines, Respiratory (COPD), Dermatology - Melanoma 
  • Study management ? all activities (planning, performance, completion)
  • feasibility, decision site selection
  • planning, tactics and strategies
  • planning internal/external resources
  • member of several taskforces
  • communication ECs/HAs/IRBs
  • establish robust relationships with KOLs and all relevant stakeholders
  • defining timelines
  • tracking project progress; define and track KPIs
  • study budget and forecasting
  • organizing Investigator meetings
  • supervision supply chain etc.

Roche GER
1 Jahr 2 Monate
2009-09 - 2010-10

Study management ? all activities

Senior Clinical Project Manager/Clinical Operations, Team Lead
Senior Clinical Project Manager/Clinical Operations, Team Lead
  • Study management ? all activities (planning, performance, completion)
  • selection and supervision of vendors and sites
  • decision selection of sites
  • supervision qualification visits, site initiation, performance overall
  • import/export licenses for material and IMP
  • cooperation/supervision third party vendors
  • set-up/maintenance eTMF
  • communication ECs/HAs/IRBs
  • contracts execution and invoices; establish robust relationships with KOLs, institutions and all relevant stakeholders
  • contracts execution and invoices
  • identifying areas of concern
  • forecast
  • budget responsibility
  • accountable for recruitment
  • contingency planning
  • risk mitigation
  • CAPA etc

Newron
2 Jahre 1 Monat
2007-08 - 2009-08

Selection and supervision of vendors and sites

Senior Global Study Delivery Team Leader
Senior Global Study Delivery Team Leader
Endocrinology, Rare diseases, Respiratory (COPD), Virology 
  • Study management - all activities (planning, performance, completion)
  • additional focus on supply chain
  • selection and supervision of vendors and sites
  • contributing to site initiation
  • import/export licenses for material and IMP
  • set-up eTMF and maintenance
  • negotiating contracts execution and invoices
  • communication ECs/HAs/IRBs
  • identifying areas of concern
  • forecasting
  • budget responsibility
  • recruitment enhancement
  • contingency planning
  • risk mitigation
  • CAPA etc

AstraZeneca GER

Aus- und Weiterbildung

Aus- und Weiterbildung

2020:

Refresher ICH-GCP Diploma


2011:

Donau Universität Krems

Master of Science Clinical Research


1992:

Carl-Albrecht-Universität Kiel

Medical examination


Ongoing:

Relevant trainings and courses at different institutes and sponsors


2004 - 2004

International Clinical Project Leader


1990 - 1990

CRA/Senior CRA/Lead

Kompetenzen

Kompetenzen

Top-Skills

Clinical Research Study Management Clinical Study Services KOL-Management Budget Management Outsourcing EDC ICH-GCP Site-Management Line Management Matrix Managment Resilience Strong Communication Skills Pharmaceutical Knowledge Local Regional Global Biopharmaceutical Knowledge All Phases Supervision CTMS

Produkte / Standards / Erfahrungen / Methoden

MS Office suite
EDC
ePRO
eCRF
CTMS
CDMS
ClinTria
Impact
numerous company related study management tool
ongoing trainings and courses
Profile:
  • Freelanced Senior Clinical Project/Study Manager with more than 20 years of extensive expertise
  • Management outsourced/in-house studies (supervision CROs/Third Parties)
  • Management Clinical Operations (development timelines, milestones, budget)
  • Main focus Oncology (Solid Tumours and Haematology studies of all phases, from CNS, Head & Neck (Glioblastoma), NSCLC, Leukaemia, ALL, CLL, Gist, Colon, Rare tumours and many more) in the last 14 years +
  • Realizing variances, issue management, reporting to Senior Management and Board
  • Team Lead cross-functional, multicultural/geographical diverse teams
  • First and lead contact to Authorities and Vendors (local/regional/global ? BfArM, EMA, FDA, Minzdrav RU etc), conversation, audits, visits
  • Excellent skills in communication and contract negotiations
  • Establishing strong relations with KOLs, PIs and Working Groups
  • Writing all parts of Clinical Protocols (from scratch to final - focus administrative parts, statistic, visit plans - medical part in cooperation), generating Patient Information and Patient Consent Forms, Patient Diaries, all relevant study documents
  • Study Management/Start up - submission, all start-up activities, running/maintenance, close-out, study report (Phase I-IV)
  • Permanent alignment of all KPIs (planning, performance, compliance, quality, budget, timelines), realizing variances, issue management, strong communication to all sides
  • Strong Hands-on-Mentality output oriented, in tight cooperation with all stakeholders
  • Adherence to all relevant SOPs, national/international laws, current regulations and ICH/GCP guidelines


Therapeutic Areas:

  • CNS: Major Depressions, Pain, MS, Neurology, Schizophrenia, Ischemic Stroke,
  • Cardiovascular: Anticoagulation, CABG, Hypertension, Ischemic Stroke
  • Dermatology: Merkel Cell Carcinoma, Melanoma, Skin Tumours, Basal Cell Carcinoma
  • Endocrinology: Diabetes Type II, Genetic Metabolic Disorders Morbus Pompe, Morbus Fabry
  • Oncology (Haematology, Solid Tumours) - ALL, CLL, Colon, GIST, Head & Neck, Melanoma, NSCLC, Ovarian, Pancreas, Rare Tumours, Hodgkin, Non-Hodgkin,
  • Ophthalmology: AMD, DED, ROP
  • Paediatrics: Genetic Metabolic Disorders, Morbus Fabry, Morbus Pompe
  • Psychiatry: Alzheimer`s Disease (Prodromal), Parkinson`s Disease
  • Respiratory: COPD, Pulmonary Artery Hypertension (PAH), Small-Cell-Lung-Cancer
  • Virology: Hepatitis C, Vaccines (HPV; Flu etc)


Summary:

  • Excellent organizational/analytical skills, self-propelled, self-motivating, flexible
  • Proactive approach; pragmatic, flexible, focused on targets, efficient, resilient
  • Expert Trial Management, high compliance and quality standards
  • Outstanding start-up expertise and site preparation
  • many years of expertise in Global and pan-European study management
  • Strong experience outsourced management (CROs/vendors/third parties)
  • Excellent communication skills; well-established interpersonal skills
  • well organized; expert team player; strong leadership qualities
  • Strong Hands-on-Mentality, result-oriented, driven by success
  • Prioritise and approve change requests in alignment with strategy
  • Ensuring continuous improvements; meet customer needs; maintaining validated state and inspection readiness as well as compliance
  • SCRA/LCRA - true expertise for another 10 years in local/regional/global clinical trials
  • Strong abilities to identify upcoming issues with high issue solving competences and escalating all issues as needed to the relevant department

Einsatzorte

Einsatzorte

Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

3 Monate
2024-01 - 2024-03

Diff. Indications

  • Diff. Indications, diff. companies (Freelanced, GER, CH)
  • Study management ? special tasks
  • communication ECs/HAs/IRBs
2 Jahre 10 Monate
2021-03 - 2023-12

Study management

Global Senior Clinical Manager
Global Senior Clinical Manager
Oncology, Immuno-Oncology 
  • Study management - all activities (planning, performance, completion)
  • ensuring target KPIs met; KOL management
  • line/budget/vendor management
  • ensuring quality, budget, timelines
  • reporting (status, ad  hoc etc)
  • development study strategies, study outlines
  • communication ECs/HAs/IRBs etc.

Oncology, Immuno-Oncology
1 Jahr
2020-03 - 2021-02

Various projects

Reviewer Clinical Protocol/Study Documents
Reviewer Clinical Protocol/Study Documents
  • Oncology ? Haematology, Solid Tumours (diff. companies CH, GER, A)
4 Monate
2019-11 - 2020-02

Study Start up activities

Senior Clinical Project Manager
Senior Clinical Project Manager
Oncology - Haematology, Solid Tumours (Skin), Rare diseases
  • Study Start up activities
  • communication with ECs/HAs/IRBs
  • study management overall, milestones, budget, staff and beyond

Takeda AG CH
7 Monate
2019-04 - 2019-10

Study management overal

Senior Clinical Project Manager
Senior Clinical Project Manager
Oncology ? Solid Tumours (Skin) (Global)
  • Study Start up activities
  • communication with ECs/HAs/IRBs
  • study management overall, milestones, budget, staff and beyond

4 Monate
2019-01 - 2019-04

Start Up/Study Management

Senior Clinical Research Manager
Senior Clinical Research Manager
Virology/Tumour Vaccines (IMA CH)
  • Start Up/Study Management - all responsibilities as described below

1 Jahr 9 Monate
2017-04 - 2018-12

Reviewer Clinical Protocol/Study Documents

Oncology ? Haematology, Solid Tumours (Freelanced; IMA, CH)
  • Protocol review
  • synopsis
  • communication ECs/HAs/IRBs
  • development amendments, IBs, PICs, CRFs, study manuals, study tools (feasibility questionnaires, site qualification documents, patient diaries)
  • compilation IMPD, submission packages, submission
  • creating information material (marketing/non-marketing)
  • close collaboration with KOLs
  • consultancy operational items etc
1 Jahr
2016-04 - 2017-03

Study management - all activities

Clinical Research Manager
Clinical Research Manager
Ovarian Cancer (Astellas GER), Team Lead
  • Study management - all activities (planning, performance, completion)
  • ensuring target KPIs met; KOL management
  • line, budget, vendor management
  • ensuring targets met (quality, budget, timelines); reporting (status reports, ad hoc reports)
  • development study strategies, study outlines
  • consultancy Due Diligence
  • communication ECs/HAs/IRBs etc.

1 Jahr 4 Monate
2015-04 - 2016-07

Reviewer Clinical Protocol/Study Documents

Oncology ? Haematology, Solid Tumours (Melanoma, Basal Cell Carcinoma), Onco-Immunology, MS, Virology/Vaccines (diff. companies CH)
  • Protocol review
  • synopsis
  • communication ECs/HAs/IRBs
  • development amendments, IBs, PICs, ICFs, CRFs, study manuals, study tools (feasibility questionnaires, site qualification documents, patient diaries)
  • compilation IMPD
  • submission packages
  • submissions
  • creating information material (non-marketing/ marketing)
  • consultancy KOLs and operational items etc.

2 Jahre
2013-04 - 2015-03

CRA management

Senior Clinical Project Manager, Team Lead
Senior Clinical Project Manager, Team Lead
Oncology - Haematology, Solid Tumours (Derma-Oncology), Rare diseases, Virology/Vaccines, Onco-Immunology 
  • Study management - all activities (planning, conduct, completion)
  • feasibility, forecasts
  • site selection
  • tracking site performance, enrolment
  • CRA management
  • budget, line vendor management
  • ensuring KPIs met (quality, budget, timelines)
  • identifying areas of concern
  • adherence to all relevant guidelines and regulations
  • establish robust relationships with institutions and KOL management
  • ensuring inspection readiness
  • development strategies
  • study outline
  • reporting (status reports, ad hoc reports)
  • communication ECs/HAs/IRBs
  • submission package
  • submissions
  • communication to all stakeholders as Medical Advisor with regard to upcoming questions to IMP, specific study protocols
  • Medical information services requests from PIs, site staff, internal/external stakeholders
Novartis CH
3 Monate
2013-01 - 2013-03

Submission packages

Regulatory Affairs Manager
Regulatory Affairs Manager
Oncology - Haematology, Solid Tumours (Derma-Oncology), Onco-Immunology; Rare diseases 
  • Submission packages
  • submissions
  • cross-functional cooperation with QA, Marketing
  • consultancy study program approach
  • compilation IMPD
  • supervision of all quality aspects of participating sites and qualification of relevant site staff; strategic input
  • Module 2
  • cooperation, communication ECs/HAs/IRBs etc

Novartis CH
10 Monate
2012-03 - 2012-12

Budget, line and vendor management

Senior Clinical Project Manager/Medical Advisor Oncology , Team Lead
Senior Clinical Project Manager/Medical Advisor Oncology , Team Lead
Oncology - Haematology, Solid Tumours (Derma-Oncology), Onco-Immunology, MS, Rare diseases 
  • Study management - all activities (planning, performance, completion)
  • feasibility, decision selection of sites
  • permanent control of site performance, enrolment numbers
  • strong communication with all stakeholders internal and external
  • budget, line and vendor management
  • ensuring targets met (quality, budget, timelines, DB freeze)
  • ensuring inspection readiness
  • adherence to all relevant guidelines and regulations
  • KOL management, institutions and all relevant stakeholders
  • development strategies
  • study outlines, status reports
  • communication ECs/HAs/IRBs
  • communication to all stakeholders as Medical Advisor with regard to upcoming questions to IMP, specific study protocols;
  • Medical information services requests from PIs, site staff, internal/external stakeholders etc.
Novartis CH
1 Jahr 4 Monate
2010-11 - 2012-02

Planning, tactics and strategies

Country Study Manager, Team Lead
Country Study Manager, Team Lead
Oncology, Virology/Vaccines, Respiratory (COPD), Dermatology - Melanoma 
  • Study management ? all activities (planning, performance, completion)
  • feasibility, decision site selection
  • planning, tactics and strategies
  • planning internal/external resources
  • member of several taskforces
  • communication ECs/HAs/IRBs
  • establish robust relationships with KOLs and all relevant stakeholders
  • defining timelines
  • tracking project progress; define and track KPIs
  • study budget and forecasting
  • organizing Investigator meetings
  • supervision supply chain etc.

Roche GER
1 Jahr 2 Monate
2009-09 - 2010-10

Study management ? all activities

Senior Clinical Project Manager/Clinical Operations, Team Lead
Senior Clinical Project Manager/Clinical Operations, Team Lead
  • Study management ? all activities (planning, performance, completion)
  • selection and supervision of vendors and sites
  • decision selection of sites
  • supervision qualification visits, site initiation, performance overall
  • import/export licenses for material and IMP
  • cooperation/supervision third party vendors
  • set-up/maintenance eTMF
  • communication ECs/HAs/IRBs
  • contracts execution and invoices; establish robust relationships with KOLs, institutions and all relevant stakeholders
  • contracts execution and invoices
  • identifying areas of concern
  • forecast
  • budget responsibility
  • accountable for recruitment
  • contingency planning
  • risk mitigation
  • CAPA etc

Newron
2 Jahre 1 Monat
2007-08 - 2009-08

Selection and supervision of vendors and sites

Senior Global Study Delivery Team Leader
Senior Global Study Delivery Team Leader
Endocrinology, Rare diseases, Respiratory (COPD), Virology 
  • Study management - all activities (planning, performance, completion)
  • additional focus on supply chain
  • selection and supervision of vendors and sites
  • contributing to site initiation
  • import/export licenses for material and IMP
  • set-up eTMF and maintenance
  • negotiating contracts execution and invoices
  • communication ECs/HAs/IRBs
  • identifying areas of concern
  • forecasting
  • budget responsibility
  • recruitment enhancement
  • contingency planning
  • risk mitigation
  • CAPA etc

AstraZeneca GER

Aus- und Weiterbildung

Aus- und Weiterbildung

2020:

Refresher ICH-GCP Diploma


2011:

Donau Universität Krems

Master of Science Clinical Research


1992:

Carl-Albrecht-Universität Kiel

Medical examination


Ongoing:

Relevant trainings and courses at different institutes and sponsors


2004 - 2004

International Clinical Project Leader


1990 - 1990

CRA/Senior CRA/Lead

Kompetenzen

Kompetenzen

Top-Skills

Clinical Research Study Management Clinical Study Services KOL-Management Budget Management Outsourcing EDC ICH-GCP Site-Management Line Management Matrix Managment Resilience Strong Communication Skills Pharmaceutical Knowledge Local Regional Global Biopharmaceutical Knowledge All Phases Supervision CTMS

Produkte / Standards / Erfahrungen / Methoden

MS Office suite
EDC
ePRO
eCRF
CTMS
CDMS
ClinTria
Impact
numerous company related study management tool
ongoing trainings and courses
Profile:
  • Freelanced Senior Clinical Project/Study Manager with more than 20 years of extensive expertise
  • Management outsourced/in-house studies (supervision CROs/Third Parties)
  • Management Clinical Operations (development timelines, milestones, budget)
  • Main focus Oncology (Solid Tumours and Haematology studies of all phases, from CNS, Head & Neck (Glioblastoma), NSCLC, Leukaemia, ALL, CLL, Gist, Colon, Rare tumours and many more) in the last 14 years +
  • Realizing variances, issue management, reporting to Senior Management and Board
  • Team Lead cross-functional, multicultural/geographical diverse teams
  • First and lead contact to Authorities and Vendors (local/regional/global ? BfArM, EMA, FDA, Minzdrav RU etc), conversation, audits, visits
  • Excellent skills in communication and contract negotiations
  • Establishing strong relations with KOLs, PIs and Working Groups
  • Writing all parts of Clinical Protocols (from scratch to final - focus administrative parts, statistic, visit plans - medical part in cooperation), generating Patient Information and Patient Consent Forms, Patient Diaries, all relevant study documents
  • Study Management/Start up - submission, all start-up activities, running/maintenance, close-out, study report (Phase I-IV)
  • Permanent alignment of all KPIs (planning, performance, compliance, quality, budget, timelines), realizing variances, issue management, strong communication to all sides
  • Strong Hands-on-Mentality output oriented, in tight cooperation with all stakeholders
  • Adherence to all relevant SOPs, national/international laws, current regulations and ICH/GCP guidelines


Therapeutic Areas:

  • CNS: Major Depressions, Pain, MS, Neurology, Schizophrenia, Ischemic Stroke,
  • Cardiovascular: Anticoagulation, CABG, Hypertension, Ischemic Stroke
  • Dermatology: Merkel Cell Carcinoma, Melanoma, Skin Tumours, Basal Cell Carcinoma
  • Endocrinology: Diabetes Type II, Genetic Metabolic Disorders Morbus Pompe, Morbus Fabry
  • Oncology (Haematology, Solid Tumours) - ALL, CLL, Colon, GIST, Head & Neck, Melanoma, NSCLC, Ovarian, Pancreas, Rare Tumours, Hodgkin, Non-Hodgkin,
  • Ophthalmology: AMD, DED, ROP
  • Paediatrics: Genetic Metabolic Disorders, Morbus Fabry, Morbus Pompe
  • Psychiatry: Alzheimer`s Disease (Prodromal), Parkinson`s Disease
  • Respiratory: COPD, Pulmonary Artery Hypertension (PAH), Small-Cell-Lung-Cancer
  • Virology: Hepatitis C, Vaccines (HPV; Flu etc)


Summary:

  • Excellent organizational/analytical skills, self-propelled, self-motivating, flexible
  • Proactive approach; pragmatic, flexible, focused on targets, efficient, resilient
  • Expert Trial Management, high compliance and quality standards
  • Outstanding start-up expertise and site preparation
  • many years of expertise in Global and pan-European study management
  • Strong experience outsourced management (CROs/vendors/third parties)
  • Excellent communication skills; well-established interpersonal skills
  • well organized; expert team player; strong leadership qualities
  • Strong Hands-on-Mentality, result-oriented, driven by success
  • Prioritise and approve change requests in alignment with strategy
  • Ensuring continuous improvements; meet customer needs; maintaining validated state and inspection readiness as well as compliance
  • SCRA/LCRA - true expertise for another 10 years in local/regional/global clinical trials
  • Strong abilities to identify upcoming issues with high issue solving competences and escalating all issues as needed to the relevant department

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