SRM is one of the largest multidisciplinary higher educational institutions in India, catering to over 45,000 students across 8 campuses in 5 states. Imparting education par excellence since 1985, SRM currently offers more than 300 programs in the fields of Engineering & Technology, Medicine, Dentistry and Other Health Sciences, Science & Humanities, Management, Law, Agricultural Sciences, and Hotel Management.
Post : Site Manager - Clinical Trials
Location : SRM MCH & RC, Kattankulathur
Employment Type : Full-time (On - Site)
Experience : Minimum 5 years in Clinical Trial Site Operations
Reporting To : Head, SRM CCTR and SRM CCP
Job Description
About the Role
We are seeking an experienced Site Manager - Clinical Trials to lead and oversee end-to- end clinical trial execution and site administration. The ideal candidate will be responsible for ensuring regulatory compliance, operational excellence, staff management, sponsor/CRO coordination, and smooth day-to-day site functioning across multiple studies.
This role requires a strong understanding of ICH-GCP, regulatory requirements, site operations, and people management, along with hands-on experience managing complex clinical trials.
2. Key Responsibilities Clinical Trial Operations
• Overall responsibility for planning, execution, and close-out of clinical trials at the site.
• Ensure all trials are conducted in compliance with ICH-GCP, local regulations, SOPs, and protocol requirements.
• Act as the primary point of contact for Sponsors, CROs, Monitors, Auditors, and Inspectors.
• Oversee subject recruitment, retention, and protocol adherence in coordination with investigators and CRCs.
• Ensure timely query resolution, data quality, and readiness for monitoring visits, audits, and inspections.
• Review and approve key study documents including protocols, IBs, consent forms, logs, and reports.
Regulatory & Quality Oversight
• Ensure timely EC submissions, approvals, amendments, and renewals.
• Maintain TMF / ISF completeness and inspection readiness at all times.
• Lead and support internal audits, sponsor audits, and regulatory inspections. Implement CAPA plans and drive continuous quality improvement at site level.
Site Administration & Management
• Manage site infrastructure, vendor coordination, and operational logistics.
• Oversee budget management, study financials, invoicing, and payments.
• Ensure availability and maintenance of essential equipment, supplies, and facilities Required for trials.
• Develop and maintain site SOPs and ensure staff compliance.
Team Leadership & Training
• Lead, mentor, and manage CRCs, study coordinators, research nurses, and support staff.
• Conduct training on protocols, GCP, SOPs, and site processes.
• Perform workload planning, task allocation, and performance monitoring for site staff.
• Foster a culture of quality, accountability, and patient safety.
Stakeholder Communication
• Maintain effective communication with Principal Investigators, Sub-Investigators, Sponsors, CROs, and vendors.
• Participate in feasibility assessments, site qualification visits, and study initiation activities.
• Support business development activities by showcasing site capabilities and performance metrics.
Candidate Profile
• Life Sciences graduate (Pharmacy / Science / Biotechnology / Medicine or related field).
• Minimum 5 years of experience in clinical trial site operations, with at least 2 years in a leadership/managerial role.
• Strong hands-on experience managing interventional clinical trials (Phase I—III preferred).
• Excellent knowledge of ICH-GCP, EC processes, regulatory requirements, and audit readiness.
• Proven experience in team management and site administration.
Key Skills & Competencies
• Strong leadership and people management skills
• Excellent organizational and multitasking abilities Clear communication and stakeholder management Audit and inspection readiness mindset Financial and operational oversight Problem-solving and decision-making skills
Salary : Salary will be as per institutional norms and negotiable based on experience and Qualification.
Application Process
Only candidates meeting the above qualifications and experience criteria should apply Interested Candidates should submit the following as a single PDF file in the Google form link provided:
• Cover Letter
• Updated CV
• Contact details of two professional referees.
Last Date : 21st Feb 2026
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