Sr Manager, Global Clinical Science Neuroscience - Princeton NJ

Job Description

The Senior Manager, Global Clinical Science function provides scientific expertise necessary to design and deliver clinical studies and programs.

The Senior Manager will be responsible for design and execution of assigned clinical trial activities and will work closely with clinical team members within the assigned project to execute activities associated with the conduct of clinical studies. The role may serve as Clinical Trial Lead, lead or support trial‑level activities, and co‑lead study team meetings in partnership with the GDO protocol manager and collaborate with cross‑functional study team members.

• Collaborate and liaise with external partners (e.g., KOLs).
• Seek out and enact best practices with instruction.
• Provide regular and timely updates to manager/management as requested.
• Develop protocol and ICF documents/amendments and present them to governance committees and development team meetings as required.
• Conduct literature reviews.
• Submit clinical documents to TMF.
• Develop site and CRA training materials and present them at SIVs and investigator meetings.
• Review clinical narratives.
• Monitor clinical data for specific trends.
• Develop data review plan in collaboration with data management.
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with data management/programming.
• Submit clinical contributions to clinical study reports (CSRs) and regulatory documents (e.g., IB, DSUR, PSUR, orphan annual reports, HA, EC, IRB responses) and contribute to regulatory submission.

• Education
  :
  Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). High School/GED required.
• Experience
  :
  Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations. Ability to understand assigned protocol(s) and their requirements. Basic knowledge and skills to support program‑specific data review and trend identification. Intermediate medical writing skills and medical terminology. Basic planning/project management skills (develop short‑range plans that are realistic and effective).
• Key Competency Requirements
  :
  Detail‑oriented with commitment to quality. Basic knowledge of disease area, compound, current clinical landscape. Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees. Intermediate critical thinking and problem‑solving skills. Adaptable and flexible, willing and able to adjust to multiple demands and shifting priorities; ability to meet day‑to‑day challenges with confidence and professionalism.
  
  Intermediate skills in Microsoft Word, Excel, PowerPoint and data review tools (e.g., Pt Profiles, report‑generating tools).

Domestic and international travel may be required.

• Cambridge Crossing: $173,390 - $210,110
• Madison – Giralda – NJ, US: $150,770 - $182,701
• Princeton – NJ, US: $150,770 - $182,701

Location:

Princeton, New Jersey.

Salary Range: $75,000 - $100,000.

Affiliate Sponsor:
Bristol Myers Sqibb BMS.