Project Manager – FSP Trial Lead

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

📋 Description

• Act as the Project Lead and main point of contact for sponsors

• Responsible for the overall delivery of the project, ensuring quality, timelines, and budget are met

• Set and convey customer expectations to the project team

• Ensure all internal and external escalation procedures are adhered to

• Guide cross-functional project teams to achieve or surpass deliverables

• Develop and implement study plans that facilitate successful clinical trial execution

• Collaborate closely with Global Trial and functional leads

• Define roles and communication channels for secondary project leads as necessary

• Oversee financial management at the trial level, including contract comprehension, resource allocation, management of out-of-scope activities, contract modifications, and adherence to timelines

• Facilitate the identification of project-level risks and resolution of issues

• Ensure compliance with company policies, SOPs, ICH-GCP, regulatory guidelines, and project-specific requirements

• Manage vendors as required

• Assign and prioritize tasks for project team members

⛳️ Requirements

• Bachelor of Arts or Bachelor of Science in a scientific field

• Relevant experience of 8+ years, including a minimum of 2 years in project/trial management

• Related scientific and clinical expertise

• Excellent skills in project management, risk assessment, contingency planning, and communication

• In-depth understanding of clinical development across one or more trial phases (I, II, III)

• Familiarity with cross-functional drug development

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

• Capability to establish and implement operational plans

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

• Ability to delegate and prioritize tasks in a dynamic environment

• Strong oral and written communication skills, along with presentation abilities

• Proactive, solution-focused, and adaptable to shifting priorities and circumstances

• Advanced knowledge of therapeutic areas and clinical development guidelines and directives

• Strong interpersonal and customer service skills, capable of leading, motivating, and coordinating cross-functional project teams

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

• Prior experience in the neurology therapeutic area is essential

• Willingness to travel domestically and internationally

🏝️ Benefits

• Fully remote work arrangement