Clinical Study Manager

Job Title: Clinical Study Manager-(Late- Phase Trials

Department: Clinical Operations Patient Trials

Reporting: Head of Clinical Operations / Site Head

Job Summary:

The Clinical Study Manager (CSM) will lead the planning, execution, and oversight of Phase II/III/IV and Real-World Evidence (RWE) studies conducted by VerGo. This role anchors the newly launched patient-based clinical trial service line and ensures operational excellence across multi-Centre investigator sites.

Role & responsibilities:

. Lead end-to-end study management for Phase II/III/IV trials, including protocol review, site selection, initiation, monitoring oversight, and close-out.

. Develop study timelines, risk plans, and operational strategies aligned with DCGI/CDSCO requirements.

• Coordinate cross-functional teams (Regulatory, Data Management, Biostatistics, PV, Medical Writing).
• Manage site performance, enrolment forecasting, and issue resolution.
• Ensure compliance with ICH-GCP, NDCT rules, VerGo SOPs, and 21 CFR Part 11 systems.
• Oversee vendor management (labs, imaging, logistics, EDC/CTMS providers).
• Lead study governance meetings with sponsors; maintain dashboards and progress reports.
• Support regulatory submissions and responses to DCGI queries.
• Mentor CRAs and site coordinators; build operational capability within the new service line.
• Ensure audit readiness and support sponsor/regulatory inspections.

Preferred candidate profile

Qualifications & Experience:

• Masters degree in Life Sciences, Pharmacy, or related field.
• Experience in authoring, developing and managing Clinical operations SOPs and system
• 10+ years of experience in clinical operations, with at least 3 years managing Phase II/III/IV trials.
• Strong understanding of Indian hospital networks, patient recruitment pathways, and DCGI processes.
• Experience with EDC, CTMS, and remote monitoring tools.
• Excellent communication, stakeholder management, and problem-solving skills.

Competencies

• Leadership presence
• Operational discipline
• Risk management
• Cross-functional coordination
• Sponsor engagement

Perks and Benefits

We offer Best Deserving CTC, Good Work Environment, Medical Insurance, Annual Leave with Six Days Week off in a month.