This position will assist in the planning and implementation of post-marketing clinical studies including, but not limited to, coordination of medical affairs related study activities to ensure compliance with the protocol, Good Clinical Practice (GCP), government regulations, and overall medical affairs objectives. 

• Daily activities will vary depending on the objectives of each post-marketing or vaccine development study.
• Manage contract research organization (CRO) personnel, investigators, and study sites to ensure studies are performed in compliance with the protocol, GCPs, government regulations, and overall study objectives.
• Manage key study parameters including, but not limited to, study start-up activities, supplies preparation, enrollment, data collection, and close-out.
• Ensure compliance with the study protocol, GCPs, FDA and ICH guidelines, and Standard Operating Procedures (SOPs).
• Lead monitoring oversight activities as needed, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits. Prepare and review site visit reports.
• Works within development and with other functional areas to develop study related documents including, but not limited to, protocols, informed consent forms, site training materials, CRFs, clinical monitoring plans, source document templates, and data audit worksheets.
• Organize and facilitate study meetings (e.g., cross-functional teams, investigator meeting, scientific advisory committee, steering committee meeting, CRO kick-off meetings, vendor calls, etc.).
• May assist in preparing study reports.
• May represent the department in project team meetings.
• Support the organization in maintaining a work environment that fosters learning, open communication, collaboration, integration, and teamwork.
• Other duties as assigned.

• BA/BS, RN/PA, BSN degree or equivalent, and at least 5+ years of industry clinical trial management experience. Half of this experience may be in-house (3 years) and/half gained through contract research organizations.
• Experience in one or more of the following therapeutic areas: inflammatory disease and/or infectious disease. Vaccine and/or NDA or BLA filing experience a plus.
• Proven project management skills and study leadership ability.
• Experience managing multiple projects.
• Strong knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical trials.
• Broad knowledge of FDA and ICH regulatory requirements.
• Demonstrated ability in critical thinking, problem-solving, and sound judgment.
• Excellent communication and interpersonal skills.
• Excellent computer skills: MS Word, PowerPoint, Excel (MS Project a plus).
• Personal attributes include:
  • Integrity and flexibility
  • Good organizational skills
  • Excellent attention to detail
  • Ability to prioritize and handle multiple tasks simultaneously
  • Practical approach to clinical and regulatory processes
  • Good judgment and decision-making experience
  • Action and goal-oriented
  • Collaborative and team-oriented
• Must be able to travel up to 25%.