Clinical Project Manager

  • Location: Berwyn, Pennsylvania
  • Type: Direct Hire
  • Job #17620

Location: Berwyn, PA

Are you passionate about the life sciences and would love to be part of advancing medicine in the neurosciences?  You will have the opportunity to work alongside energetic and passionate people that believe in collaboration and open feedback. A casual culture, with serious and ambitious goals. If you are a seasoned Clinical Project Manager. This may be for you!

Some things you will do in the role include:

  • Responsible for tracking study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects.
  • Assists in the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through CRO and/or investigator site contact.
  • Assists in preparing potential investigator site lists and assists with their evaluation and tracking for inclusion in the study.
  • Participates in vendor cross-functional clinical team meetings; may serve as main point of contact in study-level status updates for assigned study.
  • Attend monitoring visits / support monitoring efforts as required
  • Reviews correspondences and monitoring reports relating to the studies with support from Project Director.
  • Prepare and deliver study updates at study team meetings.
  • Coordinates the delivery of clinical trial supplies in collaboration with CRO and other Karuna team members.

Some things you will bring to the role:

  • Bachelor’s degree in life science, health-related or pharmaceutical field with advanced degrees in life science preferred but not required.
  • CNS experience required
  • At least 10 years relevant experience in Pharmaceutical, Biotech and/or CRO environment
  • Experience in phase I-III clinical studies. Global experience a highly preferred.
  • Understands and ensures adherence to SOPs, ICH/GCP, and FDA and other health authorities’ regulations, with strong understanding of inspection readiness.
  • Demonstrated experience in study management/monitoring, as well as working and negotiating with CROs.

For immediate consideration, email and mention Job#17620