Project Manager (Clinical Operations)

Arbro Pharmaceuticals; Gurugram District; On-site; INR 1,500,000 - 3,000,000; Full time

Job summary

Arbro Pharmaceuticals is seeking an experienced Senior Project Manager to own end-to-end study timelines, budgets, and milestone tracking for multiple regulatory studies in India. You will serve as primary sponsor contact and coordinate inputs from Clinical Operations, Data Management, QA, and Pharmacovigilance, driving risk-based monitoring and governance updates.

The ideal candidate has 6–8 years of CRO PM experience, hands-on budget management across multi-site studies, and solid knowledge of

Qualifications

• 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 II/III regulatory studies from start-up to close-out.
• Experience managing multi-site studies with substantial per-study budgets.
• Working knowledge of ICH-GCP, Indian regulatory framework, and standard CRO project management tools.

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 elevate 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.

Skills

Project management

Education

Life Sciences/Pharmacy degree

Job description

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 elevate 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