Job Title
Centralized Study Analyst (Clinical Study Contracts & Operations Support)
Company
Fortrea
Location
Bangalore, India
Work Type
Hybrid
Employment Type
Full-time
Job Posting
Posted 8 days ago
Application deadline: June 30, 2026
Role Summary
This role focuses on centralized coordination of clinical trial start-up activities, contract management, and protocol amendment support. It ensures that study agreements, documentation, and amendments are executed on time while maintaining compliance with regulatory and sponsor requirements.
Key Responsibilities
Clinical Trial Contracts & Site Agreements
Draft, review, negotiate, and finalize:
Clinical Trial Agreements (CTAs)
Confidentiality Agreements (CDAs)
Amendments and related site documentation
Coordinate with:
Sponsors
Legal teams
Clinical operations
Study teams
Ensure timely execution of contracts within study milestones
Track contract timelines and maintain status updates in systems (e.g., SAMS, UCV)
Manage approval workflows and obtain necessary authorizations
Ensure proper filing and documentation of executed contracts
Protocol Amendment Management
Coordinate submission and implementation of protocol amendments
Support contract and budget updates due to protocol changes
Communicate amendment requirements to study sites and stakeholders
Track amendment progress and ensure timely completion
Collaborate with Clinical Operations, Regulatory, Legal, and Finance teams
Ensure accurate documentation in tracking systems
Support resolution of site queries to avoid delays
Compliance & Quality Assurance
Ensure adherence to:
SOPs
Sponsor requirements
Quality standards
ICH-GCP guidelines
Maintain study trackers, reports, and metrics
Support audit readiness and documentation completeness
Escalate risks, delays, and operational issues
Stakeholder Coordination & Reporting
Provide regular updates to study teams and management
Collaborate with internal and external stakeholders
Support cross-functional communication for study execution
Ensure timely training and compliance activities
Process Improvement
Participate in process improvement initiatives
Support operational efficiency and workflow optimization
Contribute to departmental goals and best practices
Required Qualifications
University degree (Life Sciences preferred)
OR allied health certification (e.g., nursing, lab technology)
Equivalent experience may be considered
Experience Required
3–5 years in clinical research or related discipline
Basic experience (0–2 years) in other professional roles acceptable
Skills & Competencies
Core Skills
Strong understanding of:
Clinical trial contracting
Protocol amendment processes
Clinical research operations
Knowledge of ICH-GCP guidelines
Strong attention to detail and organizational skills
Ability to manage multiple studies under tight timelines
Communication & Coordination
Excellent stakeholder management
Strong negotiation and communication skills
Ability to coordinate across global teams
Technical Skills
Proficiency in contract tracking systems (SAMS, UCV, etc.)
Strong MS Office skills (Excel, Word, PowerPoint)
Behavioral Skills
High attention to detail
Strong teamwork and collaboration
Ability to handle multiple priorities
Problem-solving and escalation awareness
Consistent high-quality output
Work Environment
General office / hybrid work setup
Cross-functional interaction with global clinical teams
Deadline-driven and compliance-focused environment
Core Role Summary (Simple View)
This role mainly involves:
Managing clinical trial contracts and agreements
Handling protocol amendments
Coordinating across legal, clinical, and regulatory teams
Tracking study timelines and documentation
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
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Mexico |northeastern :
New Hampshire |Oklahoma :
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Washington |Delaware :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
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Netherlands |Remote Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Australia | Renfrew | Richmond Hill | Uxbridge | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
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Bangkok |Israel :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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