Company name
Bristol-Myers Squibb Company
Location
Summit, NJ, United States
Employment Type
Full-Time
Industry
Sciences, Scientist, Pharmaceutical
Posted on
Jun 11, 2020
Profile
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Position Summary / Objective
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
May serve as Clinical Trial Lead for one or more trials
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
Position 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 Requirements
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)
Experience Requirements
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)
Travel Required
Domestic and International travel may be required.
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 the resources to pursue their goals, both at work and in their personal lives.
Company: Bristol-Myers Squibb
Req Number: R1523168_EN
Updated: 2020-03-20 00:00:00.000 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.
Company info
Bristol-Myers Squibb Company
Website : http://www.bms.com