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Trial Delivery Specialist - Clinical Trial Coordination

Thermo Fisher Scientific
Thermo Fisher Scientific
3-6 years
preferred by company
10 Jan. 15, 2026
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

Job ID: R-01329124
Location: Remote, India (Fully Remote)
Employment Type: Full-Time
Function: Clinical Research Operations | Study Delivery | Trial Coordination
Work Shift: Second Shift (Afternoon Coverage)

Job Overview

We are hiring a Trial Delivery Specialist – Clinical Trial Coordination to support global clinical studies as an embedded Functional Service Provider (FSP) partner for a leading multinational biopharmaceutical organization. This execution-focused role is critical to ensuring operational excellence, inspection readiness, and end-to-end clinical trial delivery across therapeutic areas and study phases.

As part of a global study delivery team within a top-tier Contract Research Organization (CRO), you will work closely with Global Study Leaders, Study Managers, CROs, and third-party vendors to drive quality, timeline adherence, budget control, and regulatory compliance throughout the clinical trial lifecycle.

Key Responsibilities

Study Delivery & Operational Excellence

  • Partner with Global Study Leaders to monitor study conduct, proactively identify risks, and escalate issues impacting study quality, timelines, or budgets.

  • Support end-to-end study delivery from study start-up through close-out and archival, ensuring accuracy and completeness of internal systems, databases, trackers, and project plans.

  • Maintain and manage study-level documentation and tracking tools to support efficient execution and reporting.

Clinical Documentation & Planning

  • Review critical clinical documents including protocols, informed consent forms (ICFs), and study plans.

  • Support development and maintenance of monitoring plans, vendor management plans, risk management plans, and protocol deviation plans.

Cross-Functional & Country Oversight

  • Coordinate global and regional study activities, including meeting preparation, scheduling, and documentation.

  • Act as a primary point of contact for country-level oversight activities, tracking site activation, recruitment progress, data completeness, compliance metrics, protocol deviations, local budgets, and import license status.

  • Facilitate seamless communication with Regulatory Affairs, Local Operating Companies (LOCs), CROs, and external vendors.

Vendor & CRO Oversight

  • Serve as the operational point of contact for CROs and service providers, overseeing study-specific deliverables and performance.

  • Ensure vendor outputs align with contractual agreements, quality expectations, and timelines.

Clinical Supplies Management

  • Oversee delivery and continuity of investigational products (IP), clinical supplies, and study materials.

  • Identify and escalate risks related to supply chain continuity and recommend mitigation strategies.

eTMF Oversight & Inspection Readiness

  • Ensure eTMF setup, completeness, and ongoing quality control in alignment with inspection readiness standards.

  • Conduct periodic reviews, follow up on missing documents, and support safety report dissemination.

Budget & Financial Management

  • Support financial tracking, manage change orders, and ensure consistency across systems, budgets, and contractual agreements.

  • Escalate financial discrepancies and risks to appropriate study stakeholders.

Experience & Qualifications

  • Experience Required:

    • 3–6 years of experience in clinical trial coordination, study operations, or global study delivery within a CRO, pharmaceutical, or biopharmaceutical environment.

  • Education:

    • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline (Master’s degree preferred).

  • Core Competencies:

    • Strong understanding of global clinical trial operations, ICH-GCP, and regulatory requirements.

    • Hands-on experience with eTMF systems, vendor management, CRO oversight, and study tracking tools.

    • Proven ability to manage cross-functional teams and multiple stakeholders in a global environment.

    • Excellent organizational, communication, and risk management skills.

    • Comfort working in a remote, global, and matrixed team structure.

Career Development & Growth

This role offers long-term career progression within the FSP Global Study Delivery model, including pathways into Project Management, Study Operations Leadership, or Clinical Research Associate (CRA) roles. Employees benefit from structured learning, mentorship, and exposure to innovative clinical trial technologies, including AI-enabled platforms.

Why Join This Opportunity

  • Global exposure: Contribute to international clinical trials across therapeutic areas and phases.

  • End-to-end ownership: Gain experience from study start-up through close-out and inspection readiness.

  • Skill expansion: Build expertise in project management, vendor oversight, financial tracking, and risk management.

  • Innovation-driven environment: Work with modern clinical trial technologies and AI-enabled operational tools.

  • Remote flexibility: Fully remote role based in India with global collaboration.