Instagram
youtube
Facebook

Global Project Manager (Fsp), Remote (Us)

3-5 years
Not Disclosed
10 Nov. 27, 2025
Job Description
Job Type: Full Time 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

Global Project Manager (FSP) – Remote (US)

Location: Remote, North Carolina, United States
Job ID: R-01333014
Job Type: Full-Time
Category: Clinical Research


About the Role

Thermo Fisher Scientific’s Clinical Research Services team (supporting the PPD® portfolio) plays a critical role in accelerating the development of innovative therapies worldwide. As a Global Project Manager (FSP), you will lead the operational strategy, planning, and execution of global or regional clinical studies across diverse therapeutic areas. This remote, US-based role requires expertise in clinical trial oversight, vendor management, and cross-functional leadership.

This position is ideal for professionals who are highly organized, experienced in managing complex trials, and committed to ensuring high-quality, compliant study execution.


Key Responsibilities

Study Strategy & Planning

  • Lead or support operational strategy and study planning for assigned clinical programs.

  • Ensure alignment of study execution plans with the overarching Clinical Development Plan.

  • Provide expert operational input for protocol synopses, protocols, and other core study documents.

  • Challenge study teams to ensure feasibility, minimizing patient and site burden.

Study Execution & Oversight

  • Oversee global/regional clinical studies, ensuring on-time, on-budget, and quality-compliant delivery.

  • Manage Strategic Partners, CROs, and vendors per ICH-GCP standards and internal requirements.

  • Support Post-Trial Access (PTA), RATIO, and studies in wind-down where applicable.

  • Coordinate onboarding of team members and vendors to ensure operational readiness.

Risk, Quality & Compliance

  • Identify, monitor, and mitigate study risks with documented action plans.

  • Ensure inspection readiness and support regulatory inspections when required.

  • Review key monitoring plans, site outputs, audit findings, and protocol deviation trends.

  • Oversee trial audits and follow-up on CAPAs to maintain compliance.

Cross-Functional Leadership

  • Lead cross-functional study teams and ensure aligned, timely communication.

  • Participate in country and site feasibility discussions and contribute therapeutic insight.

  • Ensure operational strategies are robust, assumptions are accurate, and risk management plans are comprehensive.

Budget & Timeline Management

  • Support study budget creation, financial tracking, and external spend management.

  • Collaborate with Program Management, COM, COPL, and Finance to maintain accurate budget and enrollment forecasts.

  • Serve as the escalation point for vendor issues and support contract and budget negotiations.

Data Management & Reporting

  • Partner with Data Management to validate database timelines and lock strategies.

  • Support data review for database lock and CSR development.

  • Review internal trial reports and ensure complete documentation for TMF and regulatory filings.

Site & Vendor Management

  • Oversee vendor selection, performance management, and issue escalation.

  • Conduct Oversight Monitoring Visits when required.

  • Maintain strong site relationships to support recruitment and study progress.


Required Education, Skills & Experience

Education

  • Bachelor’s Degree (or international equivalent) required; Life Sciences preferred.

  • Advanced degrees (Master’s, Doctorate) may supplement experience requirements.

Experience Level

Minimum Experience Required: 5+ years

  • At least 5 years in the pharmaceutical or clinical research industry.

  • 3+ years of clinical study management/oversight experience, including global or international studies.

  • Experience supporting clinical trial operations (e.g., CTA/CTM, Lead CRA) is highly valuable.

  • Exposure to early-phase, Phase 2, or Phase 3 clinical studies is advantageous.

  • Experience across multiple therapeutic areas is preferred.

Skills & Competencies

  • Strong knowledge of global regulatory and compliance requirements (ICH-GCP, US CFR, EU CTD).

  • Proven project and program management skills, including timeline and budget oversight.

  • Expertise in identifying and managing risks in complex clinical trials.

  • Excellent leadership, communication, and interpersonal skills.

  • Ability to work independently, prioritize effectively, and manage multiple initiatives.

  • Experience managing enrollment challenges and site performance.

  • Fluent English communication skills (written and verbal).

  • Strong experience in cross-functional teamwork, vendor oversight, and clinical operations tools.


Travel Requirements

  • Approximately 5–20% travel, including international travel to partners, study sites, and therapeutic meetings.


Experience Level Summary

Mid-Senior Level / Global Clinical Project Manager
Minimum: 5+ years industry experience
Clinical Study Management: 3+ years required