Clinical Project Manager & Study Start-up

Over 20 years of experience in clinical research, incl. managing complex trials across various phases, specializing in oncology, cardiovascular, and immunology studies

Proficient in site management and clinical trial supplies, he has led projects globally, ensuring compliance with FDA, EMA, and ICH/GCP regulations

Strong organizational and time-management skills, adept at handling multiple priorities independently

Experienced in communication and coordination with global stakeholders

End-to-end Clinical Trial Management across Phase I–III, Phase IV and non-interventional studies

Project Management for national, regional and international clinical trials

Clinical Study Coordination in early and late-stage development

Monitoring / CRA support for Phase I–III trials

Local Trial Management and Regional Study Management

Clinical Operations support throughout the full study lifecycle

Drug Safety / Safety trial support in clinical development programs

Clinical Development consulting across multiple therapeutic areas

Clinical Trial Supply Management for global study programs

Clinical Contract Management

Patient recruitment and feasibility support

Medical Scientific Liaison (MSL) / Regional Scientific Advisor support

Management of non-interventional (NIS) and real-world evidence studies

Freelance senior PM support for complex, international trial setups

Strong experience across early phase (Phase I, PK/PD) and late phase (IIb/III) studies

Broad indication coverage including:

Oncology, Immunology, Diabetes, Infectious Diseases (HIV/HCV), Pulmonology, Neurology, Nephrology, Rheumatology, Anesthesia, Rare Diseases and Transplant

Manage Contract Management Systems (CMS)

Handle vendor and site contracts from initiation to archiving, ensuring accurate filing and database updates

Coordinate Contract Signatures

Distribute and track contracts for internal/external signatures, promote electronic signature solutions

Handle Purchase Orders & Contract Distribution

Process and distribute POs along with signed contracts to stakeholders

Archive and Redact Contracts

Scan, store, redact, and archive executed contracts in legal database, especially for audits/inspections

Support Site Contracts (including CDAs)

Track, scan, and distribute wet ink site contracts; handle courier logistics and database archiving

Manage HCP Contracts

Draft, review, circulate, and finalize contracts with Health Care Professionals, and ensure SAP/VMD data accuracy

Support e-signature training/testing for CRO partners and maintain related training materials and KPIs

Prepare documents, organize meetings, maintain department portals, and assist with travel and office needs

Adhere to SOPs, ICH/GCP, and regulatory requirements in all documentation and contract processes

Identify process inefficiencies and participate in optimizing procedures and system usage

Interim Director for Breast Cancer, Phase IIb/III

Manager for COVID-19 studies Phases I, IIb, III & Oncology: pancreatic carcinoma

Project Manager for Phase IIb and III

RSA for Immunology, CED

CRA for Cystic Fibrosis; Systemic Sclerosis; Phase IIa/b

Project Manager for Anesthesia, Phase I (PK/PD), Phase III

CDC for Biomedicines, Rheumatology, Immunology, Phase III, Clinical Operations