At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
+ 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). 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)
**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 / 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.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
**Company:** Bristol Myers Squibb
**Req Number:** R1539128
**Updated:** 2021-09-20 13:03:29.920 UTC
**Location:** Summit,New Jersey
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.