About the Company
Our client, a global pharmaceutical leader committed to strive toward better health for people worldwide through leading innovation in medicine, is currently seeking a Senior Clinical Operations Program Manager for their Neuroscience team (Late Stage). This is chance to be a vital contributor in a highly-visible role, overseeing a robust portfolio of clinical programs and their clinical studies.
The Senior Clinical Program Operations Manager will lead and direct the execution of clinical studies for our client’s late-stage neuroscience therapeutic area unit. Key responsibilities include:
- Overseeing a robust portfolio of clinical programs and their studies and collaborating with strategic partners.
- Translating the Clinical Research Plan into an optimal operational plan.
- Planning and overseeing the execution of the assigned clinical program(s) to meet necessary quality, budget and timelines.
- Program budget planning and external spend related to program execution.
- Communicating program status cost and issues to ensure timely decision-making by senior management.
- Responsible for operational risk management strategy in collaboration with strategic partners.
- Reviewing and providing expert clinical operations input into clinical documents such as IBs, INDs, and/or Investigational Medicinal Product Dossier (IMPDs), study synopsis protocols, and clinical study reports
- Ensuring adequate clinical operations resources are assigned to programs
- Supporting functional strategic initiatives and process improvements.
- Bachelor’s degree or international equivalent required, Life Sciences degree preferred, Advanced degree is highly desirable.
- 7+ years of experience in pharmaceutical industry and/or clinical research organization
- 4+ years of clinical study management experience
- Experience leading multiple late-stage Neuroscience clinical trials
- Expertise in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements is also required.
- Demonstrated excellence in project/program management and matrix leadership
- Phase 2 and 3 studies and global/international studies or programs experience
- Experience in more than one therapeutic area, including Neuroscience.
- Requires approximately 10-20 % travel, including overnight and international travel
If you are interested in this position, please send your resume to email@example.comHelp immediately