Project Manager – FSP Trial Lead
Posted 5hrs ago
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Job Description
Clinical trial Project Manager leading FSP project delivery for a clinical research organization. Managing sponsor relationships, cross-functional teams, budgets, risks, vendors, and regulatory compliance.
Responsibilities:
- Serve as Project Lead and primary sponsor contact
- Accountable for overall project delivery, including quality, time, and cost
- Establish and communicate customer expectations to the project team
- Ensure internal and external escalation pathways are followed
- Lead cross-functional project teams to meet or exceed deliverables
- Implement and execute study plans supporting successful clinical trial delivery
- Work closely with Global Trial and functional leads
- Define responsibilities and communication pathways for secondary project leads when required
- Ensure financial stewardship at trial level, including contract understanding, resource alignment, out-of-scope activity management, Con Mod negotiations, and timeline execution
- Drive project-level risk identification and issue resolution
- Ensure compliance with organization policies, SOPs, ICH-GCP, regulatory, and project-specific requirements
- Manage vendors where required
- Delegate and prioritize the workload of project team members
Requirements:
- B.A. or B. Sc. in a scientific discipline
- Previous experience comparable to 8+ years, including 2+ years of project/trial management
- Related scientific and clinical expertise
- Exceptional project-management, risk-assessment, contingency-planning, and communication skills
- Extensive knowledge of clinical development related to one or more trial phases (I, II, III)
- Knowledge of cross-functional drug development
- Expertise in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines, and regulatory requirements for clinical development
- Ability to establish and execute operational plans
- Technical and systems competency, including Microsoft Outlook, Word, Excel, PowerPoint, and organization systems
- Ability to delegate and prioritize workload in a frequently changing environment
- Effective oral, written communication, and presentation skills
- Proactive, solutions-oriented, and adaptable to changing priorities and situations
- Advanced therapeutic area knowledge and clinical development guidelines and directives
- Sound interpersonal and customer service skills, including ability to lead, motivate, and coordinate cross-functional project teams
- Ability to negotiate, persuade, and influence others, including cross-cultural awareness
- Prior neurology therapeutic experience required
- Ability to travel domestically and internationally
Benefits:
- Fully remote work arrangement



















