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
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.
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.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.
This position serves a key role within the assigned Therapeutic Area Team. The Senior Clinical Research Scientist (Sr. CRS) works closely with the study team to support the activities associated with one or more clinical studies. The Sr. CRS leads or co-leads a study or study activities. This position collaborates with clinical team members as well as with functions outside of clinical and external stakeholders to provide high quality and timely deliverables. The Sr. CRS is responsible for achievement of personal goals which support study team, project team, and franchise goals.
- Lead or support assigned study level activities for 1 or more clinical studies with minimal supervision; may lead or co-lead a study
- Thorough understanding of assigned protocol and protocol requirements; ensure protocol assessments support objectives and monitor site compliance accordingly
- Successfully plans execution of deliverables and anticipates future work
- Lead/Co-Lead or Support study start-up/conduct/close-out
activities as applicable:
- Preparation, storage, maintenance of clinical documents (TMF)
- Protocol development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments, and ensuring high quality final document)
- Review and validation of clinical study reports (CSRs); thorough understanding the connection between the data and the CSR
- Author and/or review clinical portions of Regulatory Documents (e.g., Investigator’s Brochure [IB], Development Safety Update Report [DSUR]
- Author/Review Informed Consent Forms (ICF); review/support finalization of regional and site ICFs as needed; ensure high quality, appropriate reading level text, and alignment with protocol)
- Planning of site and CRA training; including logistics, materials and presentation
- Country/site selection activities
- Author/review IVRS specifications and assess the implications of each question/answer within the IVRS pathway before approval
- Collaboration with Clinical Operations for budget preparation, CRO scope of work, etc. (i.e., review and provide feedback on activities/instructions/deliverables related to study data, IVRS, central labs, patient reported outcomes)
- Study committee (e.g., Data Monitoring Committee [DMC]) activities such as charters, meetings, presentation preparation
- Investigator Meeting (IM), SIV, and Study committee planning/facilitation/presentation
- Activities related to data generation and validation, including CRF creation, clinical data review, communication as needed to resolve data queries, draft/update/review data review plans, support Clinical Research Physician (CRP) in data review (generation of reports, action plans, trend identification), etc
- May support clinical development planning (assist CRP/Team Lead CRS with analysis of data and review of literature to support future planning)
- Collaborate with study team members (Clinical, Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management) to ensure that key milestones are met on time and with high quality
- Regularly attend and actively participate in study team and other clinical meetings
- May represent CRS function in cross functional activities
- Provide guidance and scientific expertise within team, across department, and across functions
- Lead the planning and preparations for external/stakeholder meetings (e.g., IMs, Governance)
- Present data/information to external investigators or study staff (e.g., SIV presentations)
- Identify and liaise with external partners in collaboration with the CRP
- Identify, escalate current/future issues; propose and enact solutions
- Independently and consistently enact and share best practices within TA
- May support or lead process improvement and departmental trainings activities
- May serve as peer coach; provide guidance to junior members of the team
- Set priorities and complete work independently
- Supports program level activities as needed
- Oversee tasks of CRSs when leading a study (if applicable)
- Ability to assimilate technical information quickly
- Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
- Knowledge of the establishment and operation of DMC, dose review teams, and independent response adjudication committees.
- Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
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.