Clinical Project Manager Clinical Trial Manager Clinical Supply Chain Logistics Decentralized Clinical Trials Patient Centric Services
Aktualisiert am 05.06.2024
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 05.06.2024
Verfügbar zu: 100%
davon vor Ort: 100%
Clinical Project Management
Decentralized Patient Centric Services
Clinical Supply Chain Logistics
Cross-Functional Team Leadership
Client Relationship Management
Risk Management
Budgeting and Resource Management
Project Planning and Execution
Regulatory Compliance
Trial Master File
ICH GCP
GxP
English
Proficient
Turkish
Muttersprache
German
Intermediate

Einsatzorte

Einsatzorte

Berlin (+500km)
Deutschland, Schweiz
möglich

Projekte

Projekte

3 years 11 months
2020-07 - 2024-05

Managed end-to-end clinical research projects

Clinical Project Manager
Clinical Project Manager

Managed end-to-end clinical research projects across multiple therapeutic areas, adhering to time, quality, and cost constraints. Oversaw the execution of clinical research activities, served as the primary point of contact for clients, and managed contractual deliverables and modifications. Regularly communicated project status, promptly escalated issues, and effectively troubleshooted to ensure client satisfaction.

  • Successfully delivered 11 clinical trials covering NORAM, EMEA, and APAC-I regions for a diverse client portfolio, including Big Pharma, Biopharma, and CROs.
  • Managed trials spanning Phase I to Phase IV, encompassing oncology, neurology, gastroenterology, tropical diseases, and immunology indications in both adult and pediatric populations, utilizing oral, IV, or SC injection forms for both chemical IMPs and biological ATMPs like mAbs and CAR-T cells.
  • Effectively led cross-functional teams and third-party vendors to ensure timely project delivery and compliance with local regulations, ICH GCP guidelines, SOPs, and project-specific plans.
  • Prepared and presented study-related updates, dashboards, and reports to study teams, and senior management, as well as sponsors, vendors, and partners.

Marken | UPS Healthcare Company
Belin-Hamburg
6 months
2020-01 - 2020-06

Developed feasibility metrics for clinical trials

Strategic Feasibility Analyst
Strategic Feasibility Analyst
  • Developed feasibility metrics for clinical trials aimed at maximizing patient recruitment rates per country and per site. 
  • Conducted retrospective evaluation of Sponsor's projected performance to inform site selection. Utilized benchmark analysis, country analysis, risk assessment, and scenario development to enhance feasibility assessment. 
  • Leveraged clinical trials with realistic forecasts and achievable plans to optimize trial outcomes.
Parexel
Belin-London
7 months
2019-06 - 2019-12

Collaborated closely with in-house strategy consulting teams

Pharmaceuticals Consultant
Pharmaceuticals Consultant
  • Collaborated closely with in-house strategy consulting teams of pharma and medical device companies to offer comprehensive and unbiased insights into emerging trends, technologies, and markets across pre-clinical, clinical, and post-market approved medicines and medical devices.
PreScouter
Berlin
5 years 2 months
2014-11 - 2019-12

Conducted integral membrane protein overexpression

Research Fellow
Research Fellow
  • Conducted integral membrane protein overexpression, purification, and characterization using state-of-the-art biochemical and biophysical tools to gain insights into early-stage post-natal brain development
Charité ? Universita?tsmedizin Berlin
Berlin
5 years 9 months
2014-02 - 2019-10

Conducted RNA deep sequencing

Research Fellow
Research Fellow
  • Conducted RNA deep sequencing to elucidate mechanisms underlying cerebral cortex development.
University Hospital Freiburg
Freiburg
7 months
2013-06 - 2013-12

Performed genetic assays to study adult brain neurogenesis

Research Fellow
Research Fellow
  • Performed genetic assays to study adult brain neurogenesis
University Hospital Zurich
Zurich
2 years
2010-11 - 2012-10

Established a fruit fly disease model

Preclinical Research Fellow
Preclinical Research Fellow
  • Established a fruit fly disease model for hereditary sensory autonomous neuropathy, a rare genetic disorder.
Flemish Institute for Biotechnology
Antwerp
2 years 2 months
2008-09 - 2010-10

Genetically engineered recombinant

Research Fellow
Research Fellow
  • Genetically engineered recombinant E. coli strains to produce xylanase enzymes tailored for the animal feed industry.
Scientific and Technological Research Council of Turkey
Istanbul
1 year 1 month
2007-07 - 2008-07

Conducted genetic and proteomic analyses

Research Fellow
Research Fellow
  • Conducted genetic and proteomic analyses aimed at enhancing meat quality for food industry
Agriculture and Food Development Authority of Ireland
Dublin
1 year 1 month
2005-04 - 2006-04

Conducted genetic testing within the IVF laboratory

Molecular Biologist
Molecular Biologist
  • Conducted genetic testing within the IVF laboratory.
Memorial Hospital
Istanbul

Aus- und Weiterbildung

Aus- und Weiterbildung

2019:

Medicine

Doctor of Philosophy (Ph.D.)

Charité ? Universita?tsmedizin Berlin, Berlin


2007:

Biochemistry

Master of Science (M.Sc.)

Istanbul University, Istanbul-Gent


2005:

Molecular Biology

Bachelor of Science (B.Sc.)

Istanbul University, Istanbul


CERTIFICATION

Clinical Trial Management

PAREXEL Academy


Good Clinical Practice / ICH GCP (E6)

PAREXEL Academy


Clinical Research Knowledge Assessment

ACRP ELKA-CRKA

Association of Clinical Research Professionals


Project Management Professional (PMP) Bootcamp

Skillsoft


Classic & Agile Project Management

Freie Universität Berlin


Business Processes: Modelling, Simulation, Execution

HPI Academy


Good Scientific Practice (GSP)

Charité ? Universita?tsmedizin Berlin


Entrepreneurs Business School

Berlin School of Economics and Law


Young Entrepreneurs in Science

Falling Walls Foundation

Kompetenzen

Kompetenzen

Top-Skills

Clinical Project Management Decentralized Patient Centric Services Clinical Supply Chain Logistics Cross-Functional Team Leadership Client Relationship Management Risk Management Budgeting and Resource Management Project Planning and Execution Regulatory Compliance Trial Master File ICH GCP GxP

Produkte / Standards / Erfahrungen / Methoden

Clinical Project Management
Decentralized Patient Centric Services
Clinical Supply Chain Logistics
Cross-Functional Team Leadership
Client Relationship Management
Risk Management
Budgeting and Resource Management
Project Planning and Execution
Regulatory Compliance

SUMMARY

  • Experienced Clinical Project Manager with four years of expertise in overseeing clinical research projects and ensuring their successful delivery. Proficient in cross-functional team management, client relationship cultivation, and effective communication. 
  • Skilled in implementing clinical research  methodologies,technologies, and platforms. Demonstrated ability to work independently in virtual settings with a proactive and innovative problem-solving mindset.


STRENGTHS

Strategic Problem Solving 

  • Identified and resolved critical issues affecting clinical trial deliverables


Effective Team Management 

  • Led cross-functional teams to complete clinical projects on-time and under budget


Strong Communication Skills

  • Effectively communicated project updates and statuses to stakeholders and clients


CLIENTS PORTFOLIO

  • AbbVie
  • Amgen
  • Boehringer Ingelheim
  • Chiesi
  • Takeda
  • United Therapeutics
  • Sanofi
  • Sana Biotech
  • Zenas BioPharma
  • Atea Pharmaceuticals
  • IQVIA
  • PPD
  • myTomorrows
  • Chronos
  • Altria
  • Danone
  • Thermo Fisher
  • Hill-Rom
  • Kaleo
  • Sartorius
  • Danaher


ACHIEVEMENTS

  • Cultivated and sustained positive relationships with clients, leading to repeat business opportunities.


ADDITIONAL SKILLS

  • EDC / IRT ? Endpoint / Maestro / Apollo / Solo
  • PM Software ? monday.com / MS Project
  • SaaS CRM ? Salesforce / SAP
  • Data analytics? Power BI / Tableau / Spotfire
  • Excel ? Pivots / vlookup / VBS / Macro
  • Feasibility ? IQVIA Study Optimizer, CiteLine
  • Statistics ? SPSS / GraphPad Prism


PROFFESSIONAL DEVELOPMENT

01/2020 ? 07/2020:

Role: Clinical Trial Management Program 

Customer: Parexel Academy, Berlin


Tasks:

  • Comprehensive understanding of international GCP guidelines and regulations
  • In-depth knowledge of clinical trial planning, execution, and monitoring
  • Proficient in project management, site selection, and budgeting for clinical trials
  • Hands-on experience in clinical trial operations and protocol adherence
  • Skilled in data management and regulatory compliance in clinical research

Einsatzorte

Einsatzorte

Berlin (+500km)
Deutschland, Schweiz
möglich

Projekte

Projekte

3 years 11 months
2020-07 - 2024-05

Managed end-to-end clinical research projects

Clinical Project Manager
Clinical Project Manager

Managed end-to-end clinical research projects across multiple therapeutic areas, adhering to time, quality, and cost constraints. Oversaw the execution of clinical research activities, served as the primary point of contact for clients, and managed contractual deliverables and modifications. Regularly communicated project status, promptly escalated issues, and effectively troubleshooted to ensure client satisfaction.

  • Successfully delivered 11 clinical trials covering NORAM, EMEA, and APAC-I regions for a diverse client portfolio, including Big Pharma, Biopharma, and CROs.
  • Managed trials spanning Phase I to Phase IV, encompassing oncology, neurology, gastroenterology, tropical diseases, and immunology indications in both adult and pediatric populations, utilizing oral, IV, or SC injection forms for both chemical IMPs and biological ATMPs like mAbs and CAR-T cells.
  • Effectively led cross-functional teams and third-party vendors to ensure timely project delivery and compliance with local regulations, ICH GCP guidelines, SOPs, and project-specific plans.
  • Prepared and presented study-related updates, dashboards, and reports to study teams, and senior management, as well as sponsors, vendors, and partners.

Marken | UPS Healthcare Company
Belin-Hamburg
6 months
2020-01 - 2020-06

Developed feasibility metrics for clinical trials

Strategic Feasibility Analyst
Strategic Feasibility Analyst
  • Developed feasibility metrics for clinical trials aimed at maximizing patient recruitment rates per country and per site. 
  • Conducted retrospective evaluation of Sponsor's projected performance to inform site selection. Utilized benchmark analysis, country analysis, risk assessment, and scenario development to enhance feasibility assessment. 
  • Leveraged clinical trials with realistic forecasts and achievable plans to optimize trial outcomes.
Parexel
Belin-London
7 months
2019-06 - 2019-12

Collaborated closely with in-house strategy consulting teams

Pharmaceuticals Consultant
Pharmaceuticals Consultant
  • Collaborated closely with in-house strategy consulting teams of pharma and medical device companies to offer comprehensive and unbiased insights into emerging trends, technologies, and markets across pre-clinical, clinical, and post-market approved medicines and medical devices.
PreScouter
Berlin
5 years 2 months
2014-11 - 2019-12

Conducted integral membrane protein overexpression

Research Fellow
Research Fellow
  • Conducted integral membrane protein overexpression, purification, and characterization using state-of-the-art biochemical and biophysical tools to gain insights into early-stage post-natal brain development
Charité ? Universita?tsmedizin Berlin
Berlin
5 years 9 months
2014-02 - 2019-10

Conducted RNA deep sequencing

Research Fellow
Research Fellow
  • Conducted RNA deep sequencing to elucidate mechanisms underlying cerebral cortex development.
University Hospital Freiburg
Freiburg
7 months
2013-06 - 2013-12

Performed genetic assays to study adult brain neurogenesis

Research Fellow
Research Fellow
  • Performed genetic assays to study adult brain neurogenesis
University Hospital Zurich
Zurich
2 years
2010-11 - 2012-10

Established a fruit fly disease model

Preclinical Research Fellow
Preclinical Research Fellow
  • Established a fruit fly disease model for hereditary sensory autonomous neuropathy, a rare genetic disorder.
Flemish Institute for Biotechnology
Antwerp
2 years 2 months
2008-09 - 2010-10

Genetically engineered recombinant

Research Fellow
Research Fellow
  • Genetically engineered recombinant E. coli strains to produce xylanase enzymes tailored for the animal feed industry.
Scientific and Technological Research Council of Turkey
Istanbul
1 year 1 month
2007-07 - 2008-07

Conducted genetic and proteomic analyses

Research Fellow
Research Fellow
  • Conducted genetic and proteomic analyses aimed at enhancing meat quality for food industry
Agriculture and Food Development Authority of Ireland
Dublin
1 year 1 month
2005-04 - 2006-04

Conducted genetic testing within the IVF laboratory

Molecular Biologist
Molecular Biologist
  • Conducted genetic testing within the IVF laboratory.
Memorial Hospital
Istanbul

Aus- und Weiterbildung

Aus- und Weiterbildung

2019:

Medicine

Doctor of Philosophy (Ph.D.)

Charité ? Universita?tsmedizin Berlin, Berlin


2007:

Biochemistry

Master of Science (M.Sc.)

Istanbul University, Istanbul-Gent


2005:

Molecular Biology

Bachelor of Science (B.Sc.)

Istanbul University, Istanbul


CERTIFICATION

Clinical Trial Management

PAREXEL Academy


Good Clinical Practice / ICH GCP (E6)

PAREXEL Academy


Clinical Research Knowledge Assessment

ACRP ELKA-CRKA

Association of Clinical Research Professionals


Project Management Professional (PMP) Bootcamp

Skillsoft


Classic & Agile Project Management

Freie Universität Berlin


Business Processes: Modelling, Simulation, Execution

HPI Academy


Good Scientific Practice (GSP)

Charité ? Universita?tsmedizin Berlin


Entrepreneurs Business School

Berlin School of Economics and Law


Young Entrepreneurs in Science

Falling Walls Foundation

Kompetenzen

Kompetenzen

Top-Skills

Clinical Project Management Decentralized Patient Centric Services Clinical Supply Chain Logistics Cross-Functional Team Leadership Client Relationship Management Risk Management Budgeting and Resource Management Project Planning and Execution Regulatory Compliance Trial Master File ICH GCP GxP

Produkte / Standards / Erfahrungen / Methoden

Clinical Project Management
Decentralized Patient Centric Services
Clinical Supply Chain Logistics
Cross-Functional Team Leadership
Client Relationship Management
Risk Management
Budgeting and Resource Management
Project Planning and Execution
Regulatory Compliance

SUMMARY

  • Experienced Clinical Project Manager with four years of expertise in overseeing clinical research projects and ensuring their successful delivery. Proficient in cross-functional team management, client relationship cultivation, and effective communication. 
  • Skilled in implementing clinical research  methodologies,technologies, and platforms. Demonstrated ability to work independently in virtual settings with a proactive and innovative problem-solving mindset.


STRENGTHS

Strategic Problem Solving 

  • Identified and resolved critical issues affecting clinical trial deliverables


Effective Team Management 

  • Led cross-functional teams to complete clinical projects on-time and under budget


Strong Communication Skills

  • Effectively communicated project updates and statuses to stakeholders and clients


CLIENTS PORTFOLIO

  • AbbVie
  • Amgen
  • Boehringer Ingelheim
  • Chiesi
  • Takeda
  • United Therapeutics
  • Sanofi
  • Sana Biotech
  • Zenas BioPharma
  • Atea Pharmaceuticals
  • IQVIA
  • PPD
  • myTomorrows
  • Chronos
  • Altria
  • Danone
  • Thermo Fisher
  • Hill-Rom
  • Kaleo
  • Sartorius
  • Danaher


ACHIEVEMENTS

  • Cultivated and sustained positive relationships with clients, leading to repeat business opportunities.


ADDITIONAL SKILLS

  • EDC / IRT ? Endpoint / Maestro / Apollo / Solo
  • PM Software ? monday.com / MS Project
  • SaaS CRM ? Salesforce / SAP
  • Data analytics? Power BI / Tableau / Spotfire
  • Excel ? Pivots / vlookup / VBS / Macro
  • Feasibility ? IQVIA Study Optimizer, CiteLine
  • Statistics ? SPSS / GraphPad Prism


PROFFESSIONAL DEVELOPMENT

01/2020 ? 07/2020:

Role: Clinical Trial Management Program 

Customer: Parexel Academy, Berlin


Tasks:

  • Comprehensive understanding of international GCP guidelines and regulations
  • In-depth knowledge of clinical trial planning, execution, and monitoring
  • Proficient in project management, site selection, and budgeting for clinical trials
  • Hands-on experience in clinical trial operations and protocol adherence
  • Skilled in data management and regulatory compliance in clinical research

Vertrauen Sie auf GULP

Im Bereich Freelancing
Im Bereich Arbeitnehmerüberlassung / Personalvermittlung

Fragen?

Rufen Sie uns an +49 89 500316-300 oder schreiben Sie uns:

Das GULP Freelancer-Portal

Direktester geht's nicht! Ganz einfach Freelancer finden und direkt Kontakt aufnehmen.