Role: Clinical Research Project Manager
Location: Chennai, Tamil Nadu
Experience: 10-15 Years
Requirements:
- 1012 years of direct, hands-on experience in clinical trials, with a focus on interventional studies (Phase IIV).
- Proven ability to read, interpret, and operationalize clinical trial protocols into eSource/EDC workflows.
- Experience managing end-to-end clinical trial processes including start-up, site initiation, data collection, query management, and close-out.
- Minimum 45 years of people management experience with demonstrated success mentoring and leading CDM/clinical trial teams.
- Strong expertise in clinical trial systems CTMS (CRIO preferred), eSource, and EDC platforms.
- Background in pharmaceutical, biotechnology, or CRO environments across multiple therapeutic areas.
- Thorough understanding of regulatory requirements (ICH-GCP, FDA, EMA, HIPAA).
- Experience with system validation, change control, and audit/inspection readiness.
