Education: Doctorate or related field
- Will be r esponsible for design and execution of assigned clinical trial activities and w ork closely with clinical team members within the assigned project to execute activities associated with the conduct
- May lead or support trial level activities for one or more trials with the necessary supervision
- May co- lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members
- C ollaborate and liaise with external partners (e.g., KOLs)
- P rovide 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
- Develop site and CRA training materials and present these at SIVs and Investigator meetings
- 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). Appropriate for new entrance to pharma (post fellowship/ new to industry)
- 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 )
- 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
- 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)
Cambridge Crossing: $173,390 - $210,110 Madison - Giralda - NJ - US: $150,770 - $182,701 Princeton - NJ - US: $150,770 - $182,701
Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.
For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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