Study Delivery Specialist – Clinical Operations
Location: Mumbai, India
Experience: 1 – 4 Years
Job ID: 389853
Apply By: April 8, 2026
Function: Business Process Services / Clinical Operations
Role Level: Executive
About the Role
Tata Consultancy Services (TCS) is seeking a Study Delivery Specialist (SDS) to join our Clinical Operations team in Mumbai. This role provides an exciting opportunity to contribute to end-to-end operational delivery of clinical studies, ensuring quality, regulatory compliance, and timely execution across all phases and therapeutic areas.
The SDS will collaborate closely with the Study Manager (SM) and Study Delivery Lead (SDL) to implement study strategies, maintain project plans, oversee vendor activities, and ensure successful study completion. This position is ideal for candidates with a life sciences background who are ready to drive clinical study operations and cross-functional collaboration.
Key Responsibilities
End-to-End Study Management:
Support study delivery from setup to archival, maintaining internal systems, tracking tools, and project plans (CSAP).
Collaborate cross-functionally with internal and external teams, including CROs and third-party vendors, to ensure smooth study operations.
Monitor study conduct and progress, proactively identifying, resolving, and escalating risks or issues impacting timelines, quality, or budget.
Documentation & Planning:
Review key clinical documents, including Protocols and Informed Consent Forms (ICFs).
Lead the development of study plans, including Monitoring Plans, Vendor Management Plans, Protocol Deviation Plans, Risk Management Plans, and Communication Plans.
Vendor & Country Oversight:
Serve as the primary point of contact for CROs and vendors, ensuring delivery of study-specific activities and compliance with timelines.
Oversee country-specific operations, including recruitment tracking, data completeness, regulatory approvals, protocol deviations, import licenses, and budget management.
Stakeholder Management & Coordination:
Facilitate interactions and meetings with internal teams (Regulatory, QA, LOC, Monitors) and external partners to ensure successful study delivery.
Coordinate study-related activities, ensuring alignment and communication across all stakeholders.
Desired Skills & Experience
Required:
1–4 years of clinical study operations experience in life sciences or pharmaceuticals
Experience in clinical study management, vendor oversight, and cross-functional collaboration
Strong understanding of clinical study regulations, ICH-GCP standards, and operational best practices
Excellent verbal and written communication skills in English
Strong organizational skills with attention to detail and ability to manage multiple priorities
Educational Qualifications:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related fields:
B.Pharm, M.Pharm, B.Sc, M.Sc
Preferred:
Prior experience with CRO oversight and global/local clinical study coordination
Knowledge of study tracking tools and clinical project management systems
Why TCS Clinical Operations – Mumbai
Contribute to high-impact clinical trials across multiple therapeutic areas
Work in a dynamic, collaborative, and growth-oriented environment
Gain exposure to global clinical operations and regulatory practices
Opportunity for career advancement and cross-functional skill development
SEO & GEO Keywords for Candidate Reach:
Clinical Study Jobs Mumbai, Clinical Operations Jobs India, Study Delivery Specialist TCS, Clinical Research Jobs, CRO Oversight Mumbai, Life Sciences Careers India
TCS is an equal opportunity employer, committed to diversity and inclusion. All qualified candidates are encouraged to apply, regardless of race, color, gender, age, nationality, or other protected characteristics.
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