Clinical Trial Manager

Role : Clinical Trial Manager

Location : Chennai, Tamil Nadu

Experience : 10-15 Years

Requirements :

• 10–12 years of direct, hands-on experience in clinical trials, with a focus on interventional studies (Phase I–IV).
• 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 4–5 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.

Skills Required

Fda, ctms, System Validation, Hipaa, crio , Regulatory Requirements, Change Control