Project Manager – Sponsor Dedicated, Inflammation

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

📋 Description

• Offer direction and daily supervision for the effective management of all facets of international clinical trials within assigned budgets and timelines.

• Liaise with functional peers to discuss project status and challenges, ensuring that project team objectives are achieved.

• Supervise operational components and execution of assigned clinical trials, encompassing study initiation, enrollment, maintenance, and closure.

• Prepare and/or assist in the creation of study-related documents, such as clinical protocols, informed consent forms, pharmacy manuals, monitoring plans, CRFs, CRF completion guidelines, study plans, and clinical study reports.

• Coordinate the review of data to support interim and final data analysis.

• Engage in the development of study strategies.

• Maintain study schedules.

• Contribute to the formulation of study budgets.

• Assist in the creation of RFPs and participate in the selection of CROs/vendors.

• Provide guidance and training to CROs, vendors, investigators, and study coordinators on study requirements.

• Oversee CRO interactions and sponsor supervision of operational functional activities.

• Proactively identify study issues and risks, suggesting or implementing solutions.

• Organize and manage internal team meetings, investigator meetings, and other trial-specific gatherings.

• Participate in the recruitment and hiring of CPA/CTMAs while supporting their professional growth.

• Mentor team members and ensure compliance with established guidelines.

⛳️ Requirements

• Extensive knowledge of clinical research and a comprehensive understanding of clinical trial methodology.

• Significant experience in study start-up processes.

• Experience with global clinical trials.

• Previous involvement in inflammation studies.

• Proficient in formulating trial plans, including site monitoring plans, risk mitigation strategies, site selection, and management of clinical supplies.

• Strong leadership capabilities to effectively guide a clinical study team.

• Ability to handle time constraints, incomplete information, or unforeseen events.

• Must demonstrate strong analytical and problem-solving abilities.

• Attention to detail is crucial.

• Exceptional organizational skills with the capability to manage multiple tasks and prioritize effectively.

• Excellent interpersonal, verbal, and written communication skills are essential.

• Comfortable working in a fast-paced corporate environment and able to adapt workload according to shifting priorities.

• Equivalent experience, skills, and/or education will also be taken into account.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition and a total rewards program.

• Medical, dental, and vision health benefits.

• Company-matched 401k.

• Eligibility to participate in the Employee Stock Purchase Plan.

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

• Flexible paid time off (PTO) and sick time.

• Company car or car allowance may be included.