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 timeframes.
Role type
Clinical Trial Manager (CTM)
Builds
Clinical deliverables (clean data) for pharma/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, team leadership, monitoring plan development, query resolution
Preferred skills
Clinical Study Manager (CSM) responsibilities, accompanied field visits (AFVs), ethics committee interaction, DCGI/Regulatory Authority engagement
Technologies
Outlook, Excel, Word, automated clinical systems
Responsibilities
Manage clinical operational and quality aspects of allocated studies; Develop clinical tools (Monitoring Plan, Guidelines) and Trial Master File sections; Collaborate with teams to meet project deliverables and timelines; Monitor clinical trials and manage CRF collection/query resolution; Coordinate start-up activities and regulatory submissions; Communicate with study sites on protocol and patient participation issues; Manage clinical resources and project financials.
Seniority
Mid-level, hands-on IC
