Project Manager (Clinical Operations)

Role & responsibilities

Own end-to-end study timelines, budgets, and milestone tracking for 23 concurrent regulatory

studies

• Serve as primary sponsor point of contact for assigned studies, managing expectations and

communication cadence

• Coordinate cross-functional inputs from Clinical Operations, Data Management, Quality

Assurance, and Pharmacovigilance

• Manage risk-based monitoring plans and escalate delivery risks proactively to the Clinical

Operations Team Lead

• Prepare and present study status updates for internal governance and sponsor review meetings
• Own study budget tracking, including site payments, vendor invoices, and change order

management

• Lead study start-up activities, including site feasibility, contract negotiation support, and regulatory

submission planning

• Drive study close-out activities, including final data lock coordination, CSR timeline management,

and archival requirements

Preferred candidate profile

Bachelor's or Master's in Life Sciences, Pharmacy, or related field

• 6-8 years of project management experience in a CRO, with direct experience managing Phase

IIIII regulatory studies from start-up to close-out

• Demonstrated experience managing full eTMF and independent sponsor communication without

escalation

• Experience managing multi-site studies with substantial per-study budgets
• Working knowledge of ICH-GCP, Indian regulatory framework, and standard CRO project

management tools