R&D Clinical Trial Support Manager
Core
Supports clinical study leaders in the execution and delivery of clinical studies, managing documentation, budgets, vendor activities, and clinical sample management.
Role type
Clinical Trial Support Manager
Builds
Clinical study operational plans, documentation, and logistics for drug development trials
Domain
Pharmaceutical clinical trials / Regulatory compliance
Deliverable
client delivery
Required skills
Clinical operations management, Study Risk Management Plan (SRMP) development, Monitoring Plan (MP) creation, Budget tracking and reconciliation, Vendor management, Clinical sample management, Investigational Medicinal Product (IMP) logistics, Pre-Approval Inspection (PAI) preparation, Data review and cleaning support, Meeting organization and leadership
Preferred skills
Advanced degree in scientific discipline, Experience with FDA/EMA regulations, Proficiency in digital tools for quality oversight
Technologies
CTMS reports, PAI Tools kit, Sharepoint, Trial Master File (TMF)
Responsibilities
Prepare study-related plans and materials including risk and monitoring plans; Review and maintain study documentation in the Trial Master File; Develop and manage study budgets and track expenditures; Oversee outsourced vendor activities and deliverables; Manage clinical sample collection, tracking, and analysis; Support Pre-Approval Inspection (PAI) preparations and audit responses; Lead study team and vendor meetings.
Seniority
Mid-level, hands-on IC
