Senior Clinical Trial Manager (Sr. CTM)
Core
Manage end-to-end clinical trial start-up and clinical deliverables for moderate to high complexity studies in Cardiovascular, Internal Medicine, and other therapeutic areas, ensuring compliance with ICH GCP and meeting customer timelines/budgets.
Role type
Senior Clinical Trial Manager (Sr. CTM)
Builds
Clinical trial start-up packages, monitoring plans, Trial Master Files, and essential documents for pharma/biotech clients.
Domain
Clinical Research / Life Sciences / Pharma
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
End-to-end clinical trial start-up management, ICH GCP compliance, cross-functional collaboration, resource management, risk management, financial acumen, regulatory submission coordination, team leadership, data quality management
Preferred skills
APAC region experience, Clinical Study Manager (CSM) responsibilities, process improvement, accompanied field visits (AFVs)
Technologies
Outlook, Excel, Word, automated clinical trial systems
Responsibilities
Manage all clinical and start-up activities for allocated studies; Act as primary point of contact for site activation and study start-up; Develop start-up tools and Trial Master File sections; Coordinate with regulatory, clinical teams, and study sites; Monitor project timelines, metrics, and financials; Ensure regulatory compliance and ethics committee follow-up.
Seniority
Senior, hands-on IC with potential for regional lead responsibilities
