Trial Delivery Specialist – Clinical Trial Coordination
Location: Remote, India
Job Type: Full-Time
Work Mode: Fully Remote
Shift: Second Shift (Afternoon)
Job ID: R-01329124
Category: Clinical Research / Study Operations
About the Role
We are seeking a Trial Delivery Specialist – Clinical Trial Coordination to support global clinical studies for a leading biopharmaceutical organization focused on vaccines, general medicines, and specialty therapies. This role operates under an embedded Functional Service Provider (FSP) model, serving as a strategic extension of the client’s global study delivery team.
As part of a globally recognized Contract Research Organization (CRO), you will contribute to the successful execution of clinical trials across multiple phases and therapeutic areas, ensuring high standards of quality, compliance, and operational excellence throughout the study lifecycle.
Role Overview
This execution-driven global role is responsible for coordinating end-to-end clinical trial delivery activities. You will collaborate closely with Global Study Leaders, Study Managers, CROs, and third-party vendors to ensure seamless trial operations, inspection readiness, and adherence to timelines, budgets, and regulatory requirements.
The position emphasizes trial coordination, eTMF oversight, vendor management, country oversight, and clinical supply coordination, supporting efficient and high-quality study delivery.
Key Responsibilities
Clinical Trial Operations & Study Delivery
Partner with Global Study Leaders to monitor study progress and proactively identify, resolve, and escalate operational risks related to quality, timelines, and budget.
Support end-to-end study execution from study start-up through close-out and archival.
Maintain and ensure accuracy of internal systems, study databases, tracking tools, and project plans.
Study Documentation & Planning
Review essential clinical documents, including study protocols and informed consent forms.
Support development and maintenance of monitoring plans, vendor management plans, risk management plans, and protocol deviation management plans.
Cross-Functional & Stakeholder Coordination
Coordinate study-related activities and manage cross-functional team communications.
Prepare, schedule, and facilitate study team meetings.
Act as a liaison between internal teams and external stakeholders, including Regulatory, Local Operating Companies (LOCs), CROs, and vendors.
Country & Site Oversight
Serve as a primary point of contact for assigned countries.
Track patient recruitment, data completeness, compliance metrics, protocol deviations, local budgets, and import license status.
Vendor & CRO Oversight
Lead vendor management and CRO oversight activities.
Monitor study-specific deliverables and ensure timely execution against contractual obligations.
Clinical Supplies Management
Oversee delivery and continuity of investigational products (IP), clinical supplies, and study materials.
Identify supply risks and recommend mitigation strategies to study teams.
eTMF & Inspection Readiness
Ensure inspection readiness through robust eTMF oversight, including setup, periodic reviews, document completeness, quality verification, and safety report dissemination.
Budget & Financial Management
Manage change orders, track expenses, and ensure alignment across systems and agreements.
Escalate financial risks or inconsistencies to study stakeholders.
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, or a related field (Master’s degree preferred).
3–6 years of experience in clinical trial coordination, study operations, or global clinical research within a CRO, sponsor, or FSP environment.
Strong understanding of ICH-GCP guidelines, clinical trial processes, and regulatory requirements.
Hands-on experience with eTMF systems, vendor management, CRO oversight, and study tracking tools.
Proven ability to manage multiple studies or complex projects in a global, cross-functional setting.
Excellent communication, organizational, and stakeholder management skills.
Experience working on global or multi-country clinical trials is highly desirable.
Career Growth & Development
This role offers long-term career progression within Global Study Delivery, Project Management, Study Operations, or Clinical Research Associate (CRA) pathways. The FSP model supports continuous professional development through structured learning programs, mentorship, and exposure to global clinical trials.
Why Join Us
Global Exposure: Work on international clinical trials across phases and therapeutic areas.
End-to-End Ownership: Gain hands-on experience from study setup to close-out.
Skill Advancement: Strengthen project management, financial oversight, data analysis, and risk management capabilities.
Innovation-Driven Environment: Gain exposure to emerging clinical trial technologies, including AI-enabled platforms.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Bangor | Brewer |New Jersey :
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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 :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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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 :
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Wavre |Tipperary :
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Swords |Republic of China :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
Witney |Ontario :
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Peru | Argentina |Brazil :
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Auckland |New Zealand :
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Barcelona |Madrid :
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Croatia |Zagreb :
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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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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Be'Er Sheva | Tel Aviv | Netanya | Yavne | Kfar Saba |Remote :
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Ciudad de México | New Mexico |Dubai :
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Khulais | Najran | Jeddah | Rabigh | King Abdullah Economic City | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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