PHARMAFull time
Clinical Study Manager - Local Studies
By Admin · Clinical Research & Clinical Operations
MUMBAI (IN)ONSITEPOSTED: 11/1/2026
PHARMAFull time
HIRING ORGANIZATIONROCHEPharmaceuticals and Diagnostics
ROLE OVERVIEW
Roche is hiring a Clinical Study Manager for local studies at its Mumbai head office. The role leads country-level study teams and oversees the operational delivery of assigned local clinical studies from preparation through close-out, within Roche quality standards, regulations and agreed budgets.
ROLE DEFINITION & RESPONSIBILITIES
- •Hold accountability and oversight for assigned local studies at country level and keep study plans for timelines, budget, resources, risk and quality updated in Roche planning systems.
- •Lead local study teams, represent Country/Region Clinical Operations at the global study management team, and share affiliate feedback with global teams.
- •Coordinate with the global study team on daily study activities, including monitoring report review, issue escalation and tracking of safety procedures.
- •Provide operational oversight of Investigator-initiated studies and Compassionate Use studies against quality and safety standards, regulations, timelines and budget allocation.
- •Coach and support study team members through effective communication, and oversee Clinical Research Organisation staff to ensure country- and site-level delivery.
- •Oversee study feasibility, site monitoring performance, Risk Based Monitoring plans and eTMF completeness, including compliance activities such as translations.
- •Support negotiation of site budgets within Fair Market Value guidelines and oversee site payments as per contract.
- •Take part in quality and compliance reviews, internal audits and regulatory inspections, maintaining inspection readiness and completing Corrective and Preventative Actions.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- University degree or equivalent.
- Professional qualification preferably in a medical or science-related field.
- Overall experience of at least 5 years in the Pharmaceutical / Biotech / Clinical Research industry.
- Minimum 5 years of experience in Clinical Operations.
- Experience covering clinical operations and quality assurance.
- Willingness to relocate.
- For internal hires: minimum 1 year completed with Roche Pharma.
PREFERRED QUALIFICATIONS
- •Pharmaceutical medicine training.
- •Higher degree and/or specialist accreditation.
REQUIRED VERIFIED SKILLS
ICH-GCP
Indian regulations
Clinical operations technical expertise
Vendor management
Multiple therapy area knowledge
Collaboration and networking
Influencing skills
Servant leadership
Patient-centric decision making
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
ORGANIZATION CONTEXT & CULTURE
Roche is a global healthcare company operating in pharmaceuticals and diagnostics, with more than 100,000 employees. The company states that its medicines treat over 26 million people and that more than 30 billion tests have been conducted using its Diagnostics products.
INDUSTRY: Pharmaceuticals and Diagnostics
APPLICATION ADVISORY
Emphasise your minimum five years in clinical operations alongside your knowledge of ICH-GCP and Indian regulations, since the posting lists both as core requirements. Bring out any experience with local Phase 4, non-interventional, Investigator-initiated or Compassionate Use studies, as well as CRO oversight, eTMF completeness, site budget work within Fair Market Value guidelines and inspection readiness.
SPONSORED · TRAINING
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