Fatih I. - Senior Project Manager – Home Health Care Services

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Berlin, Germany

Experience

Aug 2025 - Present

5 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 encompassing 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, hosting KOMs
Conducted protocol-specific site training, CRA and CTM trainings, and served as first contact point for sites and sponsors
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

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 clinical trials across therapeutic areas covering NORAM, EMEA, and APAC regions
Managed trials spanning Phase I to Phase IV, encompassing oncology, autoimmune, infectious, CNS, respiratory, cardiovascular, gastroenterology, metabolic, and rare disease indications in adult, pediatric, and geriatric populations
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
Oversaw creation of protocol, lab manual, eTMF, ICF, eCRF, patient dosing diary, protocol-specific site trainings, home care provider and agency trainings, delegation of authority forms, IRT setup, booking form creation, Investigator Meetings, Clinical Trial Questionnaire, logistics line setups, direct site communication, TMF and ISF maintenance, coordination and training of CRAs and CTMs, adverse event reporting, QMS recording, database lock, and archiving
Prepared project management plans, budgets, work orders, change orders, vendor and procurement contracts, acting as primary interface with clients and vendors
Attended audits as first escalation and contact point; logged issues in QMS, prepared CAPA plans and CIRs
Trained Business Developers, prepared capability and feasibility metrics, drafted RFPs, attended early-stage client calls and bid defenses as SME
Delivered business analysis and monthly KPI reports to executive leadership, driving efficiency within time, quality, and budget constraints
Managed one Project Coordinator as a direct report
Established a 3rd 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 insights into emerging trends, technologies, and markets at pre-clinical, clinical, and post-market stages
Served 8 medical and pharmaceutical companies with 12 business intelligence projects

Nov 2014 - Dec 2019

5 years 2 months

Berlin, Germany

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 understanding of brain development

Feb 2014 - Oct 2024

10 years 9 months

Freiburg im Breisgau, Germany

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

Zürich, Switzerland

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 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 and financial reports for 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 tasks to support project and departmental objectives