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
Gujarat :
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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McFarland | Green Way | Springville | Nairobi | Remote - South America (Latin Americal) | French | Melbourne | Remote, USA | Zaragoza | Medan | Lenexa | Switzerland | Remote - Africa | Bountiful | Remote | Castlebar | Leinster | Bishop | Lousiana | Thailand | Regulatory Labeling Manager (NA and LATAM Only) | Hungary | Texas | Riga | Faridabad | Remote - Europe | Belgium | Tulsa | Minnesota | Ireland | Remote - Middle East | Hammond | Manipal | Slovakia | Victoria | Blue Bell | Xzagreb |Republic of Colombia :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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