Clinical Trial Manager - FSP
Core
Manage clinical operational and quality aspects of low to moderate complexity studies locally in India, ensuring final clean data deliverables within contractual timelines.
Role type
Clinical Trial Manager (CTM)
Builds
Clinical deliverables (clean data) for pharmaceutical/biotech clients
Domain
Clinical Research / Life Sciences
Required skills
Clinical trial management, ICH GCP compliance, site contract negotiation, regulatory submission coordination, resource management, financial forecasting, monitoring visit execution, CRF query resolution, ethics committee interaction
Preferred skills
Clinical Study Manager (CSM) responsibilities, accompanied field visits (AFVs), bid defense preparation, team mentoring
Technologies
Outlook, Excel, Word, automated clinical systems
Responsibilities
Develop clinical tools (Monitoring Plans, Guidelines), manage Trial Master File setup, coordinate start-up activities and regulatory submissions, monitor clinical trials and review visit reports, manage clinical resources and budgets, communicate with study sites on protocol and patient participation issues
Seniority
Mid-level, hands-on IC
