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Trial Delivery Specialist – Clinical Trial Coordination

2-5 years
Not Disclosed
10 Nov. 25, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Trial Delivery Specialist – Clinical Trial Coordination

Location: Remote, India
Job Type: Full-Time
Category: Clinical Research
Work Mode: Fully Remote

About the Role

A global leader in biopharmaceutical innovation is seeking a Trial Delivery Specialist – Clinical Trial Coordination to support end-to-end study operations across phases and therapeutic areas. As part of an embedded FSP partnership, you will work as an extension of the sponsor’s global study team, ensuring operational excellence, compliance, and seamless coordination throughout the clinical trial lifecycle.


Key Responsibilities

Operational Study Coordination

  • Partner with global study leaders to track study conduct, progress, timelines, and quality metrics.

  • Identify risks, propose mitigation strategies, and escalate issues impacting delivery or compliance.

  • Manage end-to-end operational tasks from study setup to archival, ensuring completeness of tracking tools, databases, and project plans.

Clinical Documentation & Planning

  • Review essential study documents such as protocols and informed consent forms.

  • Support development of operational plans including monitoring plans, risk management plans, and vendor management plans.

Cross-Functional Communication

  • Coordinate study team communications across regulatory teams, country operations, CROs, and external vendors.

  • Organize and facilitate project meetings, ensuring timely follow-up on actions and deliverables.

Country Oversight

  • Monitor recruitment progress, data quality, protocol deviations, budget status, and import license activities.

  • Serve as a key liaison for country-level clinical operations.

Vendor & CRO Oversight

  • Act as the primary contact for vendors and CRO partners.

  • Oversee deliverables, performance, timelines, and quality adherence.

Clinical Supply Management

  • Coordinate delivery of clinical supplies, investigational products, and study materials.

  • Identify supply chain risks and communicate mitigation needs to study teams.

eTMF Oversight

  • Ensure inspection-ready eTMF documentation through setup, periodic reviews, and quality assessment.

  • Follow up on missing documents and ensure accuracy and completeness of entries.

Budget & Financial Tracking

  • Support change order management, expense tracking, and financial consistency across systems and agreements.

  • Escalate discrepancies to study stakeholders.


Required Qualifications

Education

  • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field.

Experience

  • 2–5 years of experience in clinical research, study coordination, or clinical trial operations.

  • Experience with global clinical studies, vendor management, eTMF oversight, or CRO coordination preferred.

  • Strong understanding of ICH-GCP guidelines and regulatory requirements.

  • Prior experience in multinational or FSP clinical trial environments is an advantage.


Key Skills

  • Strong project management and organizational skills.

  • Ability to coordinate multiple stakeholders across global teams.

  • Proficiency in clinical systems, eTMF platforms, and study tracking tools.

  • Excellent communication, analytical, and problem-solving abilities.

  • Ability to work independently in a remote, fast-paced environment.


Career Growth Opportunities

The FSP model provides access to structured learning pathways, mentorship, and global exposure. Career advancement can follow tracks such as:

  • Project Management / Study Operations

  • Clinical Monitoring / Clinical Research Associate (CRA)

  • Global Study Delivery & Coordination


Why Join

  • Work on global clinical trials across multiple phases and therapeutic areas.

  • Contribute to meaningful research that brings life-changing therapies to patients worldwide.

  • Gain experience with next-generation clinical technologies, including AI-enabled study platforms.

  • Be part of a collaborative, diverse, and growth-focused global study delivery team.