Clinical Operations Management
- Manage and oversee clinical trial sites for a Site Management Organization (SMO) with over 20 sites.
- Plan, implement, and monitor clinical studies, ensuring completion within timelines, budgets, and regulatory compliance.
- Ensure 100% patient recruitment and retention in compliance with GCP and relevant regulations.
- Coordinate with hospital management, physicians, sponsors, regulatory agencies, and patients.
Team Leadership & Training
- Guide, mentor, and train Trial Managers, Clinical Research Coordinators, Trial Administrators, EC Administrators, and Course Administrators.
- Organize staff training programs, periodic site team meetings, and review meetings.
- Lead cross-functional teams for operational excellence and staff development.
Quality Assurance & Compliance
- Audit clinical, laboratory, bioanalytical, pharmacokinetic, biostatistics, and pharmacovigilance operations across India and abroad.
- Ensure quality and compliance of clinical trials, in-house clinical facilities, data management, statistical programming, and medical writing.
- Develop, review, and approve SOPs, manuals, and quality systems aligned with regulatory guidelines (GCP, GLP, US FDA, ICH, ANVISA, UK-MHRA, WHO).
- Host regulatory inspections and sponsor audits; manage responses to queries from sponsors and regulatory authorities.
Clinical Trial Strategy & Documentation
- Review clinical trial protocols, site qualifications, monitoring reports, TMF, eCRF, SAP plans, CDISC datasets, and source data templates.
- Prepare biowaivers, scientific justifications, clinical study reports, and regulatory submission documents (M5 module eCTD).
- Monitor outsourced clinical studies and manage regulatory deficiencies on submitted dossiers.
Process Optimization & Reporting
- Optimize costs, resources, and operational efficiency to improve organizational profitability.
- Monitor and expedite progress of ongoing projects; plan and schedule future studies.
- Conduct Quality Management Reviews with cross-functional heads to ensure compliance.
