Manager, Clinical Trial Operations

Position Overview
We are seeking an experienced Manager – CDM to join our growing team in Chennai. The successful candidate will be a Subject Matter Expert (SME) in clinical data management systems, with a strong background in clinical trials, interventional studies, and regulatory compliance.
This role requires proven expertise in eSource (CRIO), CTMS, and EDC platforms, with the ability to design, manage, and validate electronic data workflows while ensuring trial quality, compliance, and operational efficiency. The Associate Manager will oversee multiple studies, mentor team members, and ensure seamless data integration across systems.

Key Responsibilities

Clinical Trial Data Management

• Lead and oversee end-to-end CDM activities for interventional clinical trials, from study start-up to closeout.

• Interpret clinical trial protocols and translate them into eSource templates, visit structures, and data workflows.

• Mentor and guide teams in study set-up, CRIO builds, and EDC integration.

• Participate in SIVs, PSVs, and Study Kick-Off meetings, providing CDM input.

• Ensure regulatory compliance with FDA, ICH-GCP, HIPAA, and company SOPs.

CTMS & eSource Operations

• Develop and maintain eSource templates and CTMS workflows (CRIO, RealTime, Veeva Vault CTMS, or similar).

• Manage integration between CTMS, EDC, and other systems for accurate data flow.

• Supervise data entry, query management, and quality control to ensure 100% accuracy.

• Oversee system upgrades, validation activities, and 21 CFR Part 11 compliance.

Oversight & Quality

• Establish QC processes and track study progress, enrolment metrics, and milestones.

• Lead CAPA/RCA processes to maintain data integrity and operational standards.

• Develop and update SOPs and ensure adherence across studies.

• Track KPIs for data management performance and provide status reports to leadership.

Leadership & Stakeholder Engagement

• Manage cross-functional collaboration between CDM, CRCs, clinical operations, IT, and regulatory affairs.

• Mentor and develop junior staff, building competencies across the CDM team.

• Support senior management in client presentations, audits, and inspections.

• Liaise with external vendors and sponsors for data transfer and integration activities.

Qualifications- Experience

• 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.

Technical Expertise

• CTMS configuration and administration skills (CRIO knowledge is highly desirable).

• Advanced Microsoft Excel (functions, macros, data analysis).

• Strong MS Word and PowerPoint skills for documentation and presentations.

• Familiarity with 21 CFR Part 11 and Annex 11 compliance.

Core Competencies

• Clinical Trial Expertise: Demonstrated experience with interventional study design, eSource builds, and data management.

• Strategic Thinking & Process Optimization: Ability to align CDM operations with business objectives.

• Leadership & Mentorship: Skilled in team building, coaching, and performance management.

• Risk & Quality Management: Proactive approach to mitigating data and operational risks.

• Communication Excellence: Strong written, verbal, and presentation skills. Adaptability: Thrives in fast-paced, evolving regulatory environments.

Educational Background

• Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field required.

• Master's degree preferred (MBA, MS in Clinical Research, or equivalent).

• Certifications such as CCDM, CRC, or equivalent are desirable.