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Global Project Manager (Fsp), Remote (Us)

0-2 years
Not Disclosed
10 Nov. 26, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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, United States
Location: Remote, North Carolina, United States
Job ID: R-01333014
Job Type: Full Time
Category: Clinical Research
Work Model: Fully Remote

Overview
The Global Project Manager will be part of a leading clinical research team contributing to the development of innovative therapies addressing major global health challenges. This role supports the execution of clinical studies within the PPD clinical research portfolio, operating as part of a world class contract research organization. The position requires strong study oversight, cross functional leadership, and the ability to manage complex studies across global and regional settings.

Work Schedule
Standard Monday to Friday

Environment
Office based digital and remote work environment

Role Summary
The Global Project Manager, functioning as a Clinical Study Manager, is responsible for leading or supporting operational planning and execution of assigned clinical studies. The role ensures delivery of studies in accordance with clinical development objectives, ICH GCP standards, regulatory expectations, timelines, and budgets.

This position works closely with the Clinical Operations Program Lead and the Clinical Operations Manager and oversees strategic partners, CROs, and external vendors. Multiple studies or programs may be assigned, including post trial access, asset transition studies, and wind down activities.

Key Responsibilities
• Lead planning, operational strategy, and execution activities for assigned clinical trials
• Provide operational expertise and input into study protocols, synopses, and study documents
• Ensure study feasibility by evaluating patient and site burden
• Support and review study budget development and financial planning
• Participate in country and site feasibility and selection, ensuring alignment between operational plans and program strategy
• Develop, maintain, and challenge study timelines to ensure alignment with clinical development plans
• Ensure rapid issue resolution and provide guidance to CROs and strategic partners
• Oversee study budgets, external spend, enrollment tracking, and study performance metrics
• Act as the escalation point for vendors managed by CROs and strategic partners
• Lead or support selection, contracting, and oversight of CROs and vendors
• Review and approve key monitoring documents and conduct oversight monitoring visits when required
• Review and endorse study plans and meeting documentation
• Monitor protocol deviations to identify study level trends
• Ensure proper documentation and tracking of risks, issues, and decisions
• Oversee trial operational data, CTMS reviews, and internal reporting
• Partner with data management to align database lock strategy and CSR timelines
• Support data review, CSR writing, and regulatory submission preparation
• Ensure timely collection and filing of study documents into TMF
• Ensure continuous inspection readiness and support regulatory inspections
• Oversee audit preparation, responses, and CAPA follow up
• Maintain effective site relationship management

Education
• Bachelor’s Degree or international equivalent required; Life Sciences preferred

Skills
• Strong understanding of global regulatory and compliance standards including US CFR, EU CTD, and ICH GCP
• Experience in project management, study oversight, and matrix team leadership
• Strong organizational, communication, and analytical skills
• Experience leading cross functional teams, managing vendors, and resolving complex study issues
• Experience managing patient recruitment strategies and enhancing enrollment
• Strong English communication skills, written and verbal
• Ability to work independently and handle multiple priorities effectively

Experience Required
• Minimum 5 years of experience in the pharmaceutical industry or CRO environment
• Minimum 3 years of clinical study management or oversight experience, including prior experience as a clinical trial assistant, clinical research associate, or lead CRA
• Experience with global or international Phase 2 or Phase 3 clinical studies
• Experience across multiple therapeutic areas is an advantage
• Advanced degrees or relevant clinical research training may supplement experience

Travel Requirements
• Approximately 5 to 20 percent travel, including domestic and international travel to partner locations and study sites