Centralized Study Analyst
Location: Bangalore (Hybrid)
Experience: 3–5 Years
Department: Clinical Operations / Study Start-Up / Site Contracts
Industry: CRO / Pharmaceutical / Clinical Research
Job Summary
The Centralized Study Analyst is responsible for supporting clinical trial start-up and study management activities through contract administration, protocol amendment coordination, stakeholder communication, and compliance management. The role ensures timely execution of Clinical Trial Agreements (CTAs), maintenance of study documentation, tracking of study milestones, and adherence to regulatory and quality standards.
Key Responsibilities
Clinical Trial Contract Management
Draft, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Confidentiality Agreements (CDAs), amendments, and related site contracts.
Coordinate with sponsors, legal teams, clinical operations, investigators, and study teams to facilitate timely contract execution.
Manage contract timelines to ensure site activation milestones are achieved.
Facilitate internal approval processes and obtain required authorizations.
Maintain contract status updates within study tracking systems and repositories.
Identify contracting risks and escalate delays or issues impacting study timelines.
Protocol Amendment Coordination
Coordinate protocol amendment submissions and related documentation updates.
Support amendment-related contract modifications and budget revisions.
Review amendment requirements and communicate actions, timelines, and documentation needs to study teams and sites.
Track amendment progress through submission, approval, and implementation stages.
Ensure amendment documentation is maintained accurately in applicable systems.
Study Operations Support
Maintain study trackers, reports, metrics, and operational documentation.
Support site communications and follow-up activities to resolve outstanding issues.
Provide status updates to project teams and management regarding study progress.
Assist with operational activities supporting study start-up and maintenance.
Stakeholder Collaboration
Collaborate with Clinical Operations, Regulatory Affairs, Legal, Finance, and external stakeholders.
Support effective communication between study teams and investigative sites.
Participate in cross-functional meetings to ensure alignment on study deliverables.
Quality & Compliance
Ensure compliance with SOPs, sponsor requirements, ICH-GCP guidelines, and applicable regulations.
Maintain audit-ready documentation and study records.
Escalate risks, delays, and operational challenges appropriately.
Participate in process improvement initiatives and departmental objectives.
Required Qualifications
Education
Bachelor's Degree in:
Life Sciences
Pharmacy
Biotechnology
Nursing
Medical Laboratory Technology
Allied Health Sciences
Required Experience
3–5 years of experience in Clinical Research, Clinical Operations, Study Start-Up, Regulatory Affairs, or Site Management.
Experience working with clinical trial contracts, protocol amendments, or study coordination activities.
Strong understanding of clinical trial processes and regulatory requirements.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tamil nadu | Tiruchirappalli | tiruppur | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
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Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Germany | GErmany |Lower Saxony :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
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Witney |Ontario :
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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 :
Madrid |Cebu Province :
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) :
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Kyiv |Lima Region :
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