Clinical Trial Manager / Project Manager (Raleigh/Durham)
One of our partners is seeking a Clinical Trial Manager / Project Manager to join their growing team in the Raleigh/Durham area. This position is permanent and has a very competitive compensation / benefits package and great career growth opportunities!
The Clinical Trial Manager / Project Manager is responsible for the day-to-day management of one or more Company studies and will including budgeting, timeline adherence, internal and external communications, and project deliverables. Additionally, the Clinical Trial Manager / Project Manager will be responsible for assessing risk, developing contingency plans, and driving issue resolution action plans.
- Develop and refine study timelines, clinical operations plans and study monitoring plans.
- Draft study site budgets.
- Develop study documents including case report forms, informed consent forms, study manuals, pharmacy manuals, and educational materials.
- Lead kickoff and other project related meetings with cross-functional teams and project stakeholders at all levels.
- Plan, convene, and present at investigator meetings, ensuring investigative sites are trained on study procedures.
- Oversee monitoring activities at trial sites to ensure adherence to GCP and ICH guidelines, regulatory requirements, protocols, and SOPs.
- Lead ongoing study team review of data, including project checkpoints and post mortems as
- Work with study team(s) to determine patient recruitment strategies and operational feasibility and implementation of study objectives.
- Provide timely and audience specific status and communications to Senior Management and other Key Stakeholders.
- Identify and provide solutions and direction related to key cross-functional, site, and clinical trial issues.
- Participate in the preparation of the clinical sections of regulatory submissions, annual reports, investigator brochure updates and clinical study reports.
- Actively participate in vendor selection for assigned studies.
- Responsible for vendor management to ensure operational processes are maintained and projects are completed within scope.
- Minimum Bachelor’s degree in related field or equivalent experience
- Minimum 1 years’ experience as a Clinical Project Manager working directly for a CRO, Medical Device or Pharmaceutical Company
- Previous experience as a CRA working directly for a CRO or Sponsor a plus.
- Proficient with EDC systems
- Ability to travel as required (minimum at roughly 10% with potential travel OUS)