Clinical Project Manager, Clinical Trial Manager, Clinical Supply Chain Logistics, Decentralized Clinical Trials, Patient Centric Services,
Aktualisiert am 22.03.2025
Profil
Freiberufler / Selbstständiger
Remote-Arbeit
Verfügbar ab: 01.04.2025
Verfügbar zu: 80%
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
Feasibility
Machbarkeitsstudie
Feasibility Analysis
English
Proficient
Turkish
Muttersprache
German
Intermediate

Einsatzorte

Einsatzorte

Berlin (+500km)
Deutschland, Schweiz, Österreich
möglich

Projekte

Projekte

7 months
2024-07 - 2025-01

Central Lab Services

Senior Clinical Trial Project Manager
Senior Clinical Trial Project Manager

  • Managed 11 oncology projects, including 2 pre-clinical method development projects and 9 early-stage (FIH / Phase-I) clinical studies with comprehensive central lab services.
  • Delivered lab services encompassing lab manual creation, site training, logistics line setups, kitting, sample management, sample testing, QC checks, data transfers, and sample destruction.
  • Oversaw a $12M USD account, driving innovative ACGT (CAR-T, antibodies, and radioligands) for big biotech and small-cap biopharma clients.
  • Successfully completed two method development projects for Teva and Merck, securing additional clinical trial central lab service contracts.

Precision for Medicine
Berlin
4 years
2020-07 - 2024-06

Home Health Care Services

Clinical Trial Project Manager
Clinical Trial Project Manager

  • Led decentralized clinical trial logistics, including Mobile Nursing, Home Health Care, and Direct-to/Direct-from Patient Services, managing $14M USD accounts and 11 clinical trials across therapeutic areas.
  • Established a 3rd Party Central Pharmacy service line, optimized logistical plans, and ensured compliance with ICH-GCP and local regulations.
  • Managed cross-functional teams, prepared PMPs, budgets, and contracts, and acted as the primary interface with clients, ensuring successful project execution and repeat business.
  • Delivered business analysis and monthly KPI reports to executive leadership, driving efficiency and successful outcomes within time, quality, and budget constraints.

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

Developed feasibility metrics to optimize patient recruitment rates

Strategic Feasibility Analyst - Traine
Strategic Feasibility Analyst - Traine
  • Developed feasibility metrics to optimize patient recruitment rates.
  • Conducted retrospective evaluations to inform site selection and enhance trial outcomes.
  • Provided internal consulting on project management issues and identified opportunities for process and efficiency improvement.
Parexel
Belin-London
4 years 1 month
2016-06 - 2020-06

Acting as an extension to in-house strategy consulting teams

Pharmaceuticals Consultant
Pharmaceuticals Consultant
  • Acting as an extension to in-house strategy consulting teams to provide holistic and objective insights into emerging trends, technologies, and markets at pre-clinical, clinical & post-market approved medicines and medical devices.
  • Served 8 Medical and Pharmaceuticals companies with 12 Business Intelligence projects. 
PreScouter
Berlin
5 years 2 months
2014-11 - 2019-12

Conducted research on membrane protein overexpression

Research Fellow
Research Fellow
  • Conducted research on membrane protein overexpression and early-stage brain  development.
  • Published findings in peer-reviewed journals, contributing to the scientific community's understanding of brain development.
Charité ? Universita?tsmedizin Berlin
Berlin
9 months
2014-02 - 2014-10

Conducted RNA deep sequencing

Research Fellow
Research Fellow
  • Performed RNA deep sequencing to study cerebral cortex development.
  • Coordinated data gathering and prepared reports for internal and external stakeholders.
University Hospital Freiburg
Freiburg
8 months
2013-06 - 2014-01

Performed genetic assays to study adult brain neurogenesis

Research Fellow
Research Fellow
  • Conducted genetic assays to study adult brain neurogenesis.
  • Developed and implemented new research projects, ensuring compliance with regulatory guidelines.
University of Zurich
Zurich
2 years
2010-11 - 2012-10

Established a fruit fly disease model

Research Fellow
Research Fellow
  • Established a disease model for hereditary sensory autonomous neuropathy.
  • Managed project timelines, budgets, and resource plans, ensuring project milestones were met.
Flemish Institute for Biotechnology
Antwerp
2 years 2 months
2008-09 - 2010-10

Genetically engineered recombinant

Research Fellow
Research Fellow
  • Engineered recombinant E. coli strains for enzyme production.
  • Produced and distributed status, tracking, and financial reports for internal and external stakeholders.
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.
  • Ensured quality control procedures were executed and maintained documentation to approvable status.
Memorial Hospital
Istanbul

Aus- und Weiterbildung

Aus- und Weiterbildung

2019:

Medical Neurobiology

Doctor of Philosophy (Ph.D.)

Charité ? Universita?tsmedizin Berlin


2007:

Protein Biochemistry

Master of Science (M.Sc.)

Istanbul University / Gent 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

Position

Position

  • In my most recent role as Clinical Trial Project Manager at Precision for Medicine, I managed 11 oncology projects worth of $12M USD for small-cap biopharma and legacy pharma companies. Projects were covering specialty lab services for translational method development and validations and early-stage / FIH clinical studies with comprehensive central lab services. My responsibilities included overseeing lab manual creation, site training, logistics, sample management, sample testing, data transfers, and regulatory compliance. My ability to deliver high-quality outcomes was instrumental in securing additional contracts from Teva and Merck.
  • Prior to this, at Marken (UPS Healthcare), I led decentralized clinical trials for home health care services by managing $14M USD in accounts for 11 global trials in oncology, autoimmune, CNS, and rare disease indications for all phases (Phase I to IV) for adult or pediatric populations. Activities covers all site activities at patient home including IMP delivery and storage, administration, vital sign assessments, sample collections, patient specific source data creation in EDC system for TMF. I also established a commercial business line for Home Health Care services for market-approved medications and early access programs. This included creating SOPs, forms, checklists, and integrating 3rd party central pharmacy services. I successfully led two commercial programs for Chiesi and Amgen, focusing on Fabry Disease (enzyme replacement therapy via infusion) and cardiovascular disease (self-injection small peptides) respectively.
  • Moreover, while I was doing my PhD, I worked as a freelance pharmaceutical consultant at PreScouter, I conducted retrospective data analysis of clinical trials results and peer-reviewed publications to create PK-PD meta-analysis of active cannabinoids, including ?9-THC, CBD, CBG, CBN, THCA, CBDA, CBC, ?8-THC, THCV, CBV, CBL, CBT for the Altria Group. This work sharpened my skills in interpreting results to inform actionable insights for client executive team.

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 Feasibility Machbarkeitsstudie Feasibility Analysis

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, Österreich
möglich

Projekte

Projekte

7 months
2024-07 - 2025-01

Central Lab Services

Senior Clinical Trial Project Manager
Senior Clinical Trial Project Manager

  • Managed 11 oncology projects, including 2 pre-clinical method development projects and 9 early-stage (FIH / Phase-I) clinical studies with comprehensive central lab services.
  • Delivered lab services encompassing lab manual creation, site training, logistics line setups, kitting, sample management, sample testing, QC checks, data transfers, and sample destruction.
  • Oversaw a $12M USD account, driving innovative ACGT (CAR-T, antibodies, and radioligands) for big biotech and small-cap biopharma clients.
  • Successfully completed two method development projects for Teva and Merck, securing additional clinical trial central lab service contracts.

Precision for Medicine
Berlin
4 years
2020-07 - 2024-06

Home Health Care Services

Clinical Trial Project Manager
Clinical Trial Project Manager

  • Led decentralized clinical trial logistics, including Mobile Nursing, Home Health Care, and Direct-to/Direct-from Patient Services, managing $14M USD accounts and 11 clinical trials across therapeutic areas.
  • Established a 3rd Party Central Pharmacy service line, optimized logistical plans, and ensured compliance with ICH-GCP and local regulations.
  • Managed cross-functional teams, prepared PMPs, budgets, and contracts, and acted as the primary interface with clients, ensuring successful project execution and repeat business.
  • Delivered business analysis and monthly KPI reports to executive leadership, driving efficiency and successful outcomes within time, quality, and budget constraints.

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

Developed feasibility metrics to optimize patient recruitment rates

Strategic Feasibility Analyst - Traine
Strategic Feasibility Analyst - Traine
  • Developed feasibility metrics to optimize patient recruitment rates.
  • Conducted retrospective evaluations to inform site selection and enhance trial outcomes.
  • Provided internal consulting on project management issues and identified opportunities for process and efficiency improvement.
Parexel
Belin-London
4 years 1 month
2016-06 - 2020-06

Acting as an extension to in-house strategy consulting teams

Pharmaceuticals Consultant
Pharmaceuticals Consultant
  • Acting as an extension to in-house strategy consulting teams to provide holistic and objective insights into emerging trends, technologies, and markets at pre-clinical, clinical & post-market approved medicines and medical devices.
  • Served 8 Medical and Pharmaceuticals companies with 12 Business Intelligence projects. 
PreScouter
Berlin
5 years 2 months
2014-11 - 2019-12

Conducted research on membrane protein overexpression

Research Fellow
Research Fellow
  • Conducted research on membrane protein overexpression and early-stage brain  development.
  • Published findings in peer-reviewed journals, contributing to the scientific community's understanding of brain development.
Charité ? Universita?tsmedizin Berlin
Berlin
9 months
2014-02 - 2014-10

Conducted RNA deep sequencing

Research Fellow
Research Fellow
  • Performed RNA deep sequencing to study cerebral cortex development.
  • Coordinated data gathering and prepared reports for internal and external stakeholders.
University Hospital Freiburg
Freiburg
8 months
2013-06 - 2014-01

Performed genetic assays to study adult brain neurogenesis

Research Fellow
Research Fellow
  • Conducted genetic assays to study adult brain neurogenesis.
  • Developed and implemented new research projects, ensuring compliance with regulatory guidelines.
University of Zurich
Zurich
2 years
2010-11 - 2012-10

Established a fruit fly disease model

Research Fellow
Research Fellow
  • Established a disease model for hereditary sensory autonomous neuropathy.
  • Managed project timelines, budgets, and resource plans, ensuring project milestones were met.
Flemish Institute for Biotechnology
Antwerp
2 years 2 months
2008-09 - 2010-10

Genetically engineered recombinant

Research Fellow
Research Fellow
  • Engineered recombinant E. coli strains for enzyme production.
  • Produced and distributed status, tracking, and financial reports for internal and external stakeholders.
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.
  • Ensured quality control procedures were executed and maintained documentation to approvable status.
Memorial Hospital
Istanbul

Aus- und Weiterbildung

Aus- und Weiterbildung

2019:

Medical Neurobiology

Doctor of Philosophy (Ph.D.)

Charité ? Universita?tsmedizin Berlin


2007:

Protein Biochemistry

Master of Science (M.Sc.)

Istanbul University / Gent 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

Position

Position

  • In my most recent role as Clinical Trial Project Manager at Precision for Medicine, I managed 11 oncology projects worth of $12M USD for small-cap biopharma and legacy pharma companies. Projects were covering specialty lab services for translational method development and validations and early-stage / FIH clinical studies with comprehensive central lab services. My responsibilities included overseeing lab manual creation, site training, logistics, sample management, sample testing, data transfers, and regulatory compliance. My ability to deliver high-quality outcomes was instrumental in securing additional contracts from Teva and Merck.
  • Prior to this, at Marken (UPS Healthcare), I led decentralized clinical trials for home health care services by managing $14M USD in accounts for 11 global trials in oncology, autoimmune, CNS, and rare disease indications for all phases (Phase I to IV) for adult or pediatric populations. Activities covers all site activities at patient home including IMP delivery and storage, administration, vital sign assessments, sample collections, patient specific source data creation in EDC system for TMF. I also established a commercial business line for Home Health Care services for market-approved medications and early access programs. This included creating SOPs, forms, checklists, and integrating 3rd party central pharmacy services. I successfully led two commercial programs for Chiesi and Amgen, focusing on Fabry Disease (enzyme replacement therapy via infusion) and cardiovascular disease (self-injection small peptides) respectively.
  • Moreover, while I was doing my PhD, I worked as a freelance pharmaceutical consultant at PreScouter, I conducted retrospective data analysis of clinical trials results and peer-reviewed publications to create PK-PD meta-analysis of active cannabinoids, including ?9-THC, CBD, CBG, CBN, THCA, CBDA, CBC, ?8-THC, THCV, CBV, CBL, CBT for the Altria Group. This work sharpened my skills in interpreting results to inform actionable insights for client executive team.

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 Feasibility Machbarkeitsstudie Feasibility Analysis

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

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