Project Manager

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

📋 Description

• Assist in the overall project management of clinical trials under the guidance of a Project Manager Lead.

• Aid in controlling project scope, schedule, and budget across single-service, full-scope, or multiple-protocol initiatives.

• Act as a liaison with clients, vendors, and investigative sites from the development of proposals through to the final deliverables.

• Develop and maintain the Trial Master File Management (TMF) Plan.

• Evaluate the TMF for quality, completeness, and readiness for inspection.

• Coordinate and oversee study deliverables across internal departments and vendors.

• Support interim analyses, database snapshots and locks, final Clinical Study Report (CSR), and study closure activities.

• Assist in vendor identification and contracting processes.

• Manage vendors, deliverables, scope changes, and change orders.

• Provide support in resource management and transitions of team members.

• Formulate contingency plans and strategies for risk mitigation.

• Generate and maintain metric reports for clients or senior management.

• Contribute to the financial performance of studies and financial reporting.

• Participate in financial review meetings and assist in budget reconciliation and identifying overruns.

• Review and authorize site and vendor invoices.

• Represent the company to clients and communicate the status of deliverables.

• Engage in customer proposal development.

• Organize, coordinate, and present both internal and external meetings.

• Facilitate team training in accordance with protocol and project requirements.

• Enhance knowledge of the current therapeutic landscape.

⛳️ Requirements

• Bachelor’s Degree (or equivalent) in Life Sciences, Medicine, Pharmacy, Nursing, or a related field is preferred.

• Previous experience in a contract research organization (CRO), pharmaceutical, or biotechnology company is preferred.

• Experience in CRO and relevant therapeutic areas is preferred.

• Strong understanding of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.

• Excellent organizational skills.

• Strong ability to manage time effectively and work independently.

• Exceptional written and verbal English communication, presentation, and interpersonal skills.

• Capability to inform, influence, convince, and persuade stakeholders.

• Flexibility and the ability to manage multiple tasks and meet deadlines while delivering high-quality work in a dynamic environment.

• High proficiency in the English language.

• Proficient in MS Office Applications.

• Willingness to travel as required, up to 25%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical training and education in therapeutic areas.

• Peer recognition and comprehensive rewards program.

• Inclusive company culture.

• Company car or car allowance.

• Medical, Dental, and Vision health benefits.

• Company-matched 401k plan.

• Eligibility to participate in the Employee Stock Purchase Plan.

• Opportunity to earn commissions/bonuses based on individual and company performance.

• Flexible paid time off (PTO).

• Sick leave.

• Reasonable accommodations provided when appropriate.