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 current 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.
Robust 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 Workplace, Medical Insurance, Annual Leave with Six Days Week off in a month.

📌 Clinical Study Manager South Goa (India)
🏢 VerGo Pharma Research
📍 India