Senior Manager / AGM - Clinical Trial Operations

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:
Strong 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