Clinical Project Manager II / Senior Clinical Project Manager (Biopharmaceutical)

Location: Durham, North Carolina, United States; hybrid schedule with 4 days in the office and 1 day per week from home. Travel of up to 30% may be required.

Company

Develops pharmaceutical therapies for rare and life-threatening diseases and technologies intended to expand the availability of transplantable organs.

What you will do

• Lead local or regional clinical trials through start-up, execution, and close-out.
• Coordinate cross-functional teams, vendors, investigators, and clinical operations partners.
• Manage study timelines, budgets, resources, quality standards, performance metrics, and deliverables.
• Identify, resolve, and escalate risks, protocol deviations, violations, and performance concerns.
• Oversee vendor selection, negotiations, implementation, statements of work, and outsourcing relationships.
• Contribute to protocols, study documents, SOPs, process improvements, investigator meetings, and interim or primary analysis reports.

Requirements

• Clinical Project Manager II: bachelor’s degree with 8+ years or master’s degree with 6+ years of related clinical study or project management experience in CRO or pharmaceutical operations and development.
• Senior Clinical Project Manager: bachelor’s degree with 10+ years or master’s degree with 8+ years of related experience.
• Strong knowledge of GCP/ICH regulations, clinical and medical research, and all phases of clinical research.
• Experience with EDC and CTMS systems and proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
• Ability to work independently, collaborate cross-functionally, communicate with investigators and vendors, and manage demanding workloads and deadlines.
• Ability to work four days per week from the Durham, North Carolina office and travel up to 30%.

Nice to have

• Master’s degree.
• Three or more years of experience as a CRA, Clinical Manager, or Project Manager in the biopharmaceutical industry.
• RN state or compact-state licensure.
• Leadership experience involving team motivation, strategic guidance, planning, and risk evaluation.

Culture & Benefits

• Purpose-driven work focused on therapies for rare diseases and manufactured transplantable organs.
• Medical, dental, vision, and prescription coverage.
• Wellness resources, 401(k), ESPP, paid time off, and paid parental leave.
• Disability benefits and other employee benefit programs.