Senior Manager/AGM-Clinical Trial Operations-Clinical Research department

Job Location: Kandivali (W), Mumbai

Job Role:
Lead and oversee end-to-end clinical trial operations from study start-up through study close-out, ensuring timely execution and regulatory compliance.
Identify, evaluate, and select suitable clinical trial sites and investigators based on study requirements.
Conduct site feasibility assessments and coordinate with investigators and study teams to evaluate site capabilities, patient availability, and study readiness.
Coordinate study start-up activities, including site documentation, regulatory submissions, contract execution, budgeting, and site activation.
Develop and negotiate study budgets in coordination with investigators and internal stakeholders.
Plan and conduct Site Initiation Visits (SIVs), ensuring investigators and site personnel are adequately trained on the protocol, GCP, study procedures,



and regulatory requirements.
Monitor study conduct through routine Site Monitoring Visits (SMVs), ensuring subject safety, protocol compliance, data quality, and GCP adherence.

Required Skills:
Solid knowledge of clinical trial operations across Phase IIV studies and PMS studies.
Thorough understanding of clinical trial start-up, site management, monitoring, study close-out, and project management.
Sound knowledge of ICH-GCP, NDCTR, CDSCO, Schedule Y (where applicable), and international regulatory requirements.
Excellent communication, presentation and problem-solving abilities.
Willingness to travel extensively for site qualification, initiation, monitoring, and close-out visits.

Qualification : - M. Pharma

📌 Senior Manager / Agm Clinical Trial Operations Mumbai
🏢 IPCA
📍 Mumbai