Senior Manager, Global Clinical Scientist – Psychiatry

Responsibilities

• 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 these to governance committee and development team meetings as required.
• Conduct literature review.
• Submit clinical documents to TMF.
• Develop site and CRA training materials and present these 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 clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission).

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred).
• Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
• Ability to understand assigned protocol(s) and their requirements.
• Basic knowledge 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).