Recommended expert

Fatih Ipek

Senior Project Manager – Home Health Care Services

Fatih Ipek
Berlin, Germany

Experience

Aug 2025 - Present
6 months
Berlin, Germany

Senior Project Manager – Home Health Care Services

FutureMeds

  • Leading decentralized clinical trials, including mobile nursing, home health care, and direct-to/direct-from patient services
  • Managing $5M USD accounts and 10 clinical trials spanning Phase I to Phase IV across therapeutic areas (cardiology, diabetes, obesity, mitochondrial diseases) in EMEA
  • Serving a diverse client portfolio, including big pharma, biopharma, and CROs
Jul 2024 - Feb 2025
8 months
Berlin, Germany

Senior Clinical Project Manager – Central Lab Services

Precision for Medicine

  • 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: lab manual creation, site training, logistics line setups, kitting, sample management, sample testing, QC checks, data transfers, sample destruction, adverse event reporting, TMF updates, QMS recording, database lock, archiving, budgeting, forecasting, billing, change order preparations, hosting weekly client calls and KOMs
  • Conducted protocol-specific site training and CRA/CTM trainings, acting as first contact point for sites and sponsors
  • Oversaw a $12M USD account driving innovative ACGT (CAR-T, antibodies, radioligands) for big biotech and small-cap biopharma clients
  • Completed two method development projects for Teva and Merck, securing additional clinical trial central lab service contracts
Jun 2020 - Jun 2024
4 years 1 month
Berlin, Germany

Clinical Project Manager – Home Health Care Services

Marken | UPS Healthcare Company

  • Led decentralized clinical trials including mobile nursing, home health care, and direct-to/direct-from patient services managing $14M USD accounts and 11 trials across NORAM, EMEA, and APAC
  • Managed trials spanning Phase I to Phase IV in oncology, autoimmune, infectious, CNS, respiratory, cardiovascular, gastroenterology, metabolic, and rare disease indications across adult, pediatric, and geriatric populations
  • Led cross-functional teams and third-party vendors ensuring timely delivery and compliance with local regulations, ICH GCP guidelines, SOPs, and project-specific plans
  • Oversaw creation of protocol, lab manual, eTMF, ICF, eCRF, patient dosing diary, protocol-specific site trainings, home care provider/agency trainings, delegation of authority forms, IRT setup, booking forms, Investigator Meetings, clinical trial questionnaire, logistics line setups, direct site communication, TMF/ISF maintenance, CRA/CTM coordination and training, adverse event reporting, QMS recording, database lock, archiving
  • Prepared project management plans, budgets, work orders, change orders, vendor and procurement contracts; acted as primary interface with clients and vendors
  • Attended audits as first escalation point, logged issues in QMS, prepared CAPA plans and CIRs
  • Trained business developers, prepared capability and feasibility metrics, RFPs, and supported bid defenses as SME
  • Delivered business analysis and monthly KPI reports to executive leadership
  • Supervised a project coordinator as direct report
  • Established a third-party central pharmacy and depot service line by creating SOPs, forms, qualification checklists, NDAs, MSAs, STCs, conducting vendor audits, and holding weekly vendor calls for clinical trials and post-market programs
Jan 2020 - May 2020
5 months
Berlin, Germany

Strategic Feasibility Analyst – Trainee

Parexel

  • 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
Jun 2016 - May 2020
4 years
Berlin, Germany

Pharmaceuticals Consultant

PreScouter

  • Acted as an extension to in-house strategy consulting teams providing holistic, objective insights into emerging trends, technologies, and markets for pre-clinical, clinical, and post-market medicines and medical devices
  • Served 8 medical and pharmaceutical companies with 12 business intelligence projects
Nov 2014 - Dec 2019
5 years 2 months

Lab Research Fellow

Charité – Universitätsmedizin Berlin

  • 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
Feb 2014 - Oct 2014
9 months

Lab Research Fellow

University Hospital Freiburg

  • Performed RNA deep sequencing to study cerebral cortex development
  • Coordinated data gathering and prepared reports for internal and external stakeholders
Jun 2013 - Jan 2014
8 months

Lab Research Fellow

University of Zurich

  • Conducted genetic assays to study adult brain neurogenesis
  • Developed and implemented new research projects ensuring compliance with regulatory guidelines
Nov 2010 - Nov 2012
2 years 1 month
Antwerp, Belgium

Lab Research Fellow

Flemish Institute for Biotechnology

  • Established a disease model for hereditary sensory autonomous neuropathy
  • Managed project timelines, budgets, and resource plans to meet project milestones
Sep 2008 - Oct 2010
2 years 2 months
İstanbul, Turkey

Lab Research Fellow

Scientific and Technological Research Council of Turkey

  • Engineered recombinant E. coli strains for enzyme production
  • Produced and distributed status, tracking, and financial reports for internal and external stakeholders
Jul 2007 - Jul 2008
1 year 1 month
Dublin, Ireland

Lab Research Fellow

Agriculture and Food Development Authority of Ireland

  • Conducted genetic and proteomic analyses aimed at enhancing meat quality for the food industry
Apr 2005 - Apr 2006
1 year 1 month
İstanbul, Turkey

Molecular Biologist

Memorial Hospital

  • Conducted genetic testing within the IVF laboratory
  • Ensured quality control procedures were executed and maintained documentation to approvable status
Jan 2003 - Dec 2004
2 years
Munich, Germany

Intern

German Research Center for Health and Environment

  • Participated in the Chicken Genome Project conducting gene analysis and sequencing
  • Assisted senior staff with additional tasks to support project and departmental objectives

Skills

  • 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

Languages

German
Native
Turkish
Advanced
English
Elementary
Dutch
Elementary

Education

Oct 2020 - Jun 2024

Charité – Universitätsmedizin Berlin

Doctor of Philosophy in Medicine · Medicine · Berlin, Germany

Oct 2005 - Jun 2007

Istanbul University / Gent University

Master of Science in Protein Biochemistry · Protein Biochemistry · Istanbul, Turkey

Oct 2001 - Jun 2005

Istanbul University

Bachelor of Science in Molecular Biology · Molecular Biology · İstanbul, Turkey

Certifications & licenses

Clinical Trial Management Program

Parexel Academy

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