Roche Hiring for Clinical Study Manager in Mumbai

Roche is hiring for the position of Clinical Study Manager – Local Studies at its Mumbai Head Office. The opportunity is for professionals with experience in pharmaceutical, biotechnology, and clinical research industries, particularly in clinical operations and study management.

The selected candidate will lead and oversee assigned local clinical studies across preparation, study start-up, conduct, and close-out phases, ensuring compliance with Roche quality standards, applicable regulations, timelines, and budget commitments.

Job Details

Position

Clinical Study Manager – Local Studies

The position involves providing leadership to local study teams and managing the operational delivery of assigned clinical studies, including:

• Phase IV studies
• Non-interventional studies
• Investigator-Initiated Studies (IIS)
• Real-World Evidence (RWE) generation
• Compassionate Use Programs
• Post-Trial Access Programs

The role also contributes to generating safety and efficacy data from Indian patients and supporting access to innovative treatments.

Key Responsibilities

• Lead local clinical study teams and oversee assigned studies at the country level.
• Manage study plans covering timelines, budgets, resources, risks, and quality.
• Coordinate with global study teams and represent country clinical operations at global study management team meetings.
• Oversee day-to-day study activities, monitoring reports, issue resolution, and safety procedures.
• Ensure compliance with ICH-GCP, Indian regulations, Roche quality standards, and applicable clinical research requirements.
• Manage operational oversight of investigator-initiated studies and compassionate use studies.
• Identify study risks and deviations and implement appropriate mitigation strategies.
• Provide coaching, guidance, and support to study team members.
• Oversee CRO performance and coordinate with CRO management.
• Review study feasibility, site monitoring performance, Risk-Based Monitoring plans, and eTMF completeness.
• Support the development of monitoring plans, recruitment plans, and study newsletters.
• Coordinate site budget negotiations in accordance with Fair Market Value guidelines.
• Oversee site payments as per contractual requirements.
• Participate in quality reviews, internal audits, and regulatory inspections.
• Ensure inspection readiness and completion of Corrective and Preventive Actions (CAPA).
• Maintain relationships with investigator sites, alliance partners, and collaborative groups.
• Coordinate Health Authority presentations for studies and protocol amendments.

Eligibility Criteria and Qualifications

Candidates applying for the Roche Clinical Study Manager position should meet the following requirements:

• University degree or equivalent qualification.
• Professional qualification preferably in a medical or science-related field.
• Pharmaceutical medicine training is highly desirable.
• Higher degree and/or specialist accreditation is desirable.
• Minimum 5 years of overall experience in the pharmaceutical, biotechnology, or clinical research industry.
• Minimum 5 years of experience in Clinical Operations.
• Experience in clinical operations and quality assurance.
• Willingness to relocate to Mumbai.

Internal Candidates: A minimum of one year of experience with Roche Pharma is applicable for internal applicants.

Required Skills and Competencies

Functional Competencies

• Knowledge of ICH-GCP and Indian clinical research regulations.
• Knowledge of multiple therapeutic areas.
• Clinical operations expertise.
• Vendor and CRO management.
• Clinical study planning and operational oversight.
• Quality assurance and compliance.

Behavioural Competencies

• Patient-centric decision-making.
• Strong collaboration and networking skills.
• Leadership and influencing abilities.
• Servant leadership.
• Effective communication and stakeholder management.
• Alignment with Roche Core Values.