Senior Clinical Trial Manager, Fsp

1-5 years

Not Disclosed

Remote

10 Nov. 28, 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

Senior Clinical Trial Manager (FSP) – Remote (US – East Coast Preferred)

Job ID: R-01332923
Location: Remote, North Carolina, United States
Job Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote

About the Role

The Senior Clinical Trial Manager (CTM) plays a critical role in driving high-quality clinical trial delivery within a leading global Contract Research Organization (CRO). This position supports complex clinical programs within the PPD® clinical research portfolio of Thermo Fisher Scientific, enabling the development of life-changing therapies across global markets.

This role requires leadership in operational execution, quality oversight, risk mitigation, site management, and cross-functional collaboration to ensure all trials meet timelines, regulatory requirements, and client expectations.

Candidates located on the US East Coast are highly preferred due to EST working hours.
Travel Requirement: Up to 80%, depending on project needs.
Therapeutic Area Preference: Neurology or Rare Disease experience is highly desirable.

Key Responsibilities

Lead all clinical operational and quality aspects of assigned clinical studies (moderate to high complexity) in full compliance with ICH-GCP, SOPs, and regulatory standards.
Act as regional Lead CTM or Clinical Study Manager as required; oversee project coordination and process improvements.
Drive efficient study start-up activities by managing feasibility, site selection, regulatory document collection, and site initiation readiness.
Provide oversight of clinical CRO partners and ensure all EDC-related responsibilities are completed on schedule.
Support training of CRAs on study-specific activities; participate in monitor meetings and investigator meetings.
Customize and monitor Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs) as per oversight plans.
Validate essential study documents (monitoring plans, study manuals, guidelines) prepared by CRO partners.
Develop clinical tools, monitoring guidelines, and relevant documentation aligned with the Data Quality Plan and Master Action Plan.
Ensure timely and accurate setup and maintenance of the Trial Master File and support protocol-specific document development.
Collaborate with project managers, clinical teams, and cross-functional groups to maintain project quality, timelines, and communication flow.
Track trial performance using management tools, implement recovery plans, and ensure contractual deliverables are met.
Conduct accompanied field visits (AFVs), review monitoring reports, manage query resolution, and oversee CRF collection.
Guide regulatory submissions, oversee ethics committee communications, and ensure compliance with regulatory expectations.
Provide input into resource forecasting, clinical budgeting, and staffing requirements.
Maintain strong communication with study sites and internal teams to resolve protocol, documentation, and operational issues.

Required Skills & Competencies

Strong leadership, mentoring, and supervisory capabilities.
Proficiency in onsite and remote clinical monitoring.
Advanced understanding of ICH-GCP, FDA guidelines, SOPs, and clinical research methodology.
Excellent communication, documentation, negotiation, and conflict-resolution skills.
Strong analytical, organizational, and project management abilities.
Ability to manage complex studies in a fast-paced, changing environment.
Solid knowledge of medical terminology and therapeutic areas.
Proficient computer skills for data management, documentation, and reporting.
Ability to travel extensively within the US as required.

Experience Required

Minimum 5+ years of clinical research experience, including:
- At least 1 year of leadership experience in clinical operations or clinical team management.
- Mandatory experience in both on-site monitoring and CTM-level responsibilities.
2+ years of clinical experience in Neurology or Rare Disease settings is highly preferred.
Demonstrated success managing complex multi-regional clinical studies.

Why Join Thermo Fisher Scientific (PPD Clinical Research)?

Become part of a global organization dedicated to advancing scientific innovation and improving patient outcomes. With clinical trials conducted across 100+ countries and a mission to enable a healthier, cleaner, and safer world, you will contribute to meaningful research that drives global health impact.

Thermo Fisher Scientific values integrity, innovation, intensity, and involvement, fostering a collaborative environment where diverse experiences and perspectives are respected.

Equal Opportunity Statement

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other legally protected characteristic.

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Senior Clinical Trial Manager, Fsp

Job Description

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