Fatih Ipek
Senior Project Manager – Home Health Care Services
Experience
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
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
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
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
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
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
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
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
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
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
Lab Research Fellow
Agriculture and Food Development Authority of Ireland
- Conducted genetic and proteomic analyses aimed at enhancing meat quality for the food industry
Molecular Biologist
Memorial Hospital
- Conducted genetic testing within the IVF laboratory
- Ensured quality control procedures were executed and maintained documentation to approvable status
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
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Healthcare (11.5 years), Biotechnology (9.5 years), Pharmaceutical (5 years), Government and Administration (2 years), Agriculture (1 year), and Food and Beverage (1 year).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Research and Development (15 years), Project Management (7.5 years), Quality Assurance (5 years), Logistics (4 years), Business Intelligence (4 years), and Strategy (4 years).
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
Education
Charité – Universitätsmedizin Berlin
Doctor of Philosophy in Medicine · Medicine · Berlin, Germany
Istanbul University / Gent University
Master of Science in Protein Biochemistry · Protein Biochemistry · Istanbul, Turkey
Istanbul University
Bachelor of Science in Molecular Biology · Molecular Biology · İstanbul, Turkey
Certifications & licenses
Clinical Trial Management Program
Parexel Academy
Profile
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