Clinical Trial Manager

4 weeks ago

New Delhi, India Crescent Techservices Full time

Role: Clinical Trial ManagerLocation: Chennai, Tamil NaduExperience: 10-15 YearsRequirements:- 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.

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