End-to-End Trial Lifecycle: Drive operational planning, study execution, and timely delivery of global clinical trials (feasibility, site selection, SIV, monitoring, and close-out).
CRO Vendor Management: Lead selection processes (RFPs, bid defense) and oversee day-to-day CRO/vendor performance, KPIs, and deliverables.
Study Execution Site Oversight: Manage site-facing activities, enrollment tracking, compliance, and build strong relationships with investigators.
data Quality TMF: Ensure data integrity, lead risk management/mitigation planning, and maintain completeness of the Trial Master File (TMF) through to database lock.
Cross-Functional Collaboration: Represent the sponsor in internal/external meetings, collaborating with Regulatory, Safety, CMC, and Biometrics while adhering to ICH-GCP.
Requirements: Education: Bachelors degree in Life Sciences or a related field (Advanced degree - preferred).Experience: Minimum 5 years of direct clinical study management experience (or $/ge$ 5 studies), with a proven ability to lead a study independently from start to finish-Must (Sponsor CTM experience preferred).Project Management: Strong budgeting, timeline development, and risk management skills.Vendor Oversight: Proven experience in CRO selection, contracting, and governance.Systems: Familiarity with EDC, CTMS, eTMF, and clinical data management processes.Advantages: Experience in Biotech/Startups, Rare Diseases, Dermatology indications, and advanced phases (Phase 2-3).Skills: Excellent communication and leadership skills; high proficiency in English.
This position is open to all candidates.