Sr Manager, Global Clinical Science Neuroscience - Princeton NJ

Position Summary / Objective

The Senior Manager, Global Clinical Science function provides scientific expertise necessary to design and deliver clinical studies and programs. Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct.

Position Responsibilities

• Collaborate and liaise with external partners (e.g., KOLs)
• Seek out and enact best practices with instruction
• 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.)

Minimum Education Required

High School/GED

Additional Qualifications/Responsibilities

• Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Ability to understand assigned protocol(s) and their requirements
• Intermediate medical writing skills and medical terminology
• Intermediate critical thinking and problem-solving skills
• Adaptable / 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)

Travel Required

Domestic and International travel may be required.

Compensation Overview

• Cambridge Crossing: $173,390 - $210,110
• Bristol Myers Sqibb BMS: $75,000-$100,000