Trial Delivery Specialist – Clinical Trial Coordination
Location: Remote, India
Job Type: Full-Time | Fully Remote
Category: Clinical Research
Job ID: R-01329124
About the Role
We are seeking a Trial Delivery Specialist – Clinical Trial Coordination to join a leading global biopharmaceutical organization advancing vaccines, specialty medicines, and general healthcare solutions. As an embedded FSP (Functional Service Provider) study delivery partner, you will work as an integral part of the global study team, ensuring operational excellence in clinical trial management across all phases and therapeutic areas.
This remote role focuses on delivering high-quality study execution through oversight of trial coordination, data management, vendor and CRO oversight, project planning, and ensuring inspection readiness.
Key Responsibilities
Clinical Study Coordination & Execution
Partner with global study leaders to monitor study progress, identify and resolve risks, and ensure studies meet quality, timeline, and budget objectives.
Support end-to-end study operations, including study set-up, data tracking, project plans, and study archival.
Review critical clinical documents such as protocols and informed consent forms, and support the development of monitoring plans, vendor management plans, risk management plans, and deviation management strategies.
Coordinate cross-functional communication between internal teams, regulatory bodies, local country operations, CROs, and external vendors to ensure smooth study execution.
Vendor & CRO Management
Serve as primary point of contact for vendors and CROs, ensuring study-specific deliverables are met on time and in compliance with regulatory standards.
Clinical Supplies Management
Oversee clinical supplies and investigational product (IP) logistics, proactively identifying risks or issues, and recommending mitigation strategies to maintain study continuity.
Data & eTMF Oversight
Ensure study data integrity and inspection readiness by monitoring eTMF completeness, document quality, and timely submission of safety reports.
Financial & Budget Oversight
Manage change orders, track expenses, and maintain consistency between budgets, systems, and agreements, escalating discrepancies to stakeholders.
Required Qualifications & Experience
Education
Bachelor’s degree in Life Sciences, Pharmacy, or related field. Advanced degree preferred.
Experience
Minimum 3–5 years of clinical trial coordination or clinical operations experience, preferably in a CRO, pharmaceutical, or biotech environment.
Experience managing vendors, CROs, or clinical supplies is highly desirable.
Familiarity with eTMF, clinical trial documentation, and regulatory compliance.
Skills & Competencies
Strong project management, analytical, and organizational skills.
Excellent communication and collaboration skills for cross-functional and global team interaction.
Ability to manage multiple priorities and ensure deadlines are met in a fast-paced environment.
Proficient in Microsoft Office suite; experience with clinical trial systems (e.g., CTMS, EDC, eTMF) is a plus.
Detail-oriented with a proactive approach to problem-solving and risk mitigation.
Career Growth & Development
Global Exposure: Work on international clinical studies across multiple phases and therapeutic areas, collaborating with global teams and vendors.
End-to-End Study Ownership: Engage in all stages of clinical trial delivery, from study initiation to close-out.
Skill Enhancement: Gain expertise in project management, financial tracking, risk management, and new clinical trial technologies, including AI-based platforms.
Career Pathways: Opportunities to progress along the Project Management/Study Operations track or Clinical Research Associate track based on skills and impact.
Why Join Us
Contribute to life-changing therapies reaching patients worldwide.
Gain hands-on experience in global clinical trial operations and functional service delivery models.
Access continuous learning, mentorship, and development opportunities to advance your clinical research career.
Apply now on ThePharmaDaily.com to become a Trial Delivery Specialist – Clinical Trial Coordination and play a pivotal role in delivering high-quality clinical trials that impact patient lives globally.
Gujarat :
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