Project Manager – FSP Trial Lead

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Act as Project Lead and the main contact for sponsors.

• Responsible for the overall delivery of the project, ensuring quality, timeliness, and budget adherence.

• Set and communicate customer expectations to the project team.

• Ensure that both internal and external escalation procedures are properly followed.

• Lead cross-functional project teams to achieve or surpass deliverables.

• Participate as a member of the Study Management Team (SMT).

• Implement and execute study plans to facilitate successful clinical trial outcomes.

• Collaborate closely with global trial and functional leads.

• Clarify roles and communication pathways for secondary project leads when necessary.

• Exhibit financial stewardship at the trial level, which includes understanding contracts, aligning resources with the budget, managing out-of-scope activities, negotiating Contract Modifications (Con Mod), and executing timelines.

• Establish, communicate, and manage customer expectations throughout the project lifecycle.

• Drive the identification of project-level risks and resolution of issues.

• Ensure adherence to organizational policies, Standard Operating Procedures (SOPs), ICH-GCP, regulatory requirements, and project-specific standards.

• Manage vendors as necessary.

• Delegate and prioritize tasks for project team members in a dynamic environment.

⛳️ Requirements

• B.A. or B.Sc. in a scientific discipline.

• Over 8 years of relevant experience.

• At least 2 years of experience in project or trial management.

• Relevant scientific and clinical expertise.

• Outstanding project management, risk assessment, contingency planning, and communication skills.

• In-depth knowledge of clinical development related to one or more trial phases (I, II, III).

• Knowledge of cross-functional drug development.

• Proficient in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines, and regulatory requirements in clinical development.

• Capability to develop and implement operational plans.

• Technical proficiency with Microsoft Outlook, Word, Excel, PowerPoint, and organizational systems.

• Ability to delegate effectively and prioritize tasks in a frequently changing environment.

• Strong oral and written communication and presentation skills.

• Proactive, solution-oriented, and adaptable to shifting priorities and situations.

• Skill in negotiation, persuasion, and influencing others, with cross-cultural awareness.

• Prior experience in neurology therapeutics is required.

• Experience with rare diseases is preferred.

• Investigator site and/or monitoring experience is preferred.

• Experience with Functional Service Providers (FSP) is preferred.

• Willingness to travel domestically and internationally.

• An advanced degree in a related field is preferred.

🏝️ Benefits

• Opportunity to travel both domestically and internationally.