Clinical Scientist
- Employer
- Bristol Myers Squibb Company
- Location
- Summit East, NJ, United States
- Start date
- Sep 5, 2020
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- Discipline
- Clinical, Clinical Research
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Functional Area Description
The Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
About Bristol-Myers Squibb
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.
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.
Company
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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