Trial Delivery Specialist – Clinical Trial Coordination
Location: Remote, India
Job Type: Full-time | Fully Remote
Category: Clinical Research / Clinical Trial Operations
Job ID: R-01329124
Work Schedule: Second Shift (Afternoon Shift)
Experience Required: 4–7 Years
Job Overview
We are hiring a Trial Delivery Specialist – Clinical Trial Coordination to support global clinical study execution as part of a Functional Service Provider (FSP) model. This role operates as an embedded partner within a leading global biopharmaceutical organization focused on vaccines, general medicines, and specialty therapies.
As part of a high-performing global clinical research services team, you will play a critical role in ensuring operational excellence, inspection readiness, vendor oversight, and end-to-end study coordination across all phases of clinical development.
Key Responsibilities
Global Study Delivery & Coordination
Partner closely with Global Study Leaders to monitor study conduct, progress, and performance against quality, timeline, and budget objectives
Identify, assess, mitigate, and escalate operational risks impacting study delivery
Support end-to-end operational execution from study start-up through close-out and archival
Clinical Operations & Documentation
Review key clinical documents including protocols, informed consent forms, and study plans
Support development and maintenance of monitoring plans, vendor management plans, risk management plans, and protocol deviation management plans
Ensure accuracy, completeness, and timely maintenance of internal systems, databases, trackers, and project plans
Cross-Functional & Stakeholder Management
Coordinate study-related activities across cross-functional teams including Regulatory, Local Operating Companies (LOCs), CROs, and third-party vendors
Plan, prepare, schedule, and facilitate study team meetings and communications
Act as a central communication point to ensure alignment and timely execution of study deliverables
Country & Site Oversight
Support country-level oversight activities including patient recruitment tracking, data completeness, compliance monitoring, local budget tracking, protocol deviations, and import license status
Serve as a primary operational contact for country and regional stakeholders
Vendor & CRO Oversight
Act as the primary point of contact for assigned vendors and CROs
Monitor vendor performance, deliverables, timelines, and quality standards
Escalate issues and collaborate with stakeholders to ensure successful vendor execution
Clinical Supply Oversight
Oversee delivery of investigational products (IP) and study materials from external service providers
Proactively identify risks to supply continuity and recommend mitigation strategies
eTMF & Inspection Readiness
Ensure ongoing eTMF oversight and inspection readiness
Manage eTMF setup, periodic reviews, document completeness, quality checks, and follow-up on missing documentation
Oversee safety report dissemination and verification of trial master file content
Budget & Financial Management
Support financial oversight including change orders, expense tracking, and reconciliation between contracts, systems, and budgets
Escalate financial risks or inconsistencies to study stakeholders
Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, or a related discipline
Advanced degree preferred
Experience Requirements
4 to 7 years of experience in clinical trial operations, study coordination, or global study delivery
Experience working in CRO, FSP, or sponsor-embedded study management models
Hands-on experience with vendor oversight, eTMF management, and global study coordination
Core Skills & Competencies
Global clinical trial coordination
Study operations and project management
eTMF oversight and inspection readiness
Vendor and CRO management
Risk identification and mitigation
Budget and financial tracking
Strong communication and stakeholder management skills
Career Development & Growth
This role offers multiple long-term career pathways within global clinical research, including progression into Study Operations Management, Project Management, or Clinical Research Associate (CRA) tracks. The FSP model provides access to structured learning, mentorship, and stretch assignments across diverse therapeutic areas.
Why Join This Opportunity
Global exposure: Work on international clinical trials across phases and therapeutic areas
End-to-end ownership: Contribute across the full study lifecycle from start-up to close-out
Skill enhancement: Strengthen global project management, operational analytics, and risk management expertise
Innovation-driven environment: Gain exposure to modern clinical trial technologies, including AI-enabled platforms
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Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Tallinn |Hà Nội :
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