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.
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 CRS works closely with the study team to support the activities associated with a clinical study. This position collaborates with clinical team members as well as with functions outside of clinical to provide deliverables. The CRS is responsible for achievement of personal goals which support study team and project team goals.
- Support assigned study level activities with a minimal level of supervision (may lead or co-lead a study or study activities)
- Thorough understanding of assigned protocol and protocol requirements
- Successfully plans execution of deliverables
- Support all study start up/conduct/close-out activities as applicable
- Preparation, storage, maintenance of clinical documents (TMF)
- Coordination of protocols & amendments; may author with guidance
- Review and validation of clinical study reports (CSRs); demonstrate basic understanding the connection between the data and the CSR
- Conduct literature review as needed
- Provide study related information to support Regulatory Documents (e.g., IB, Briefing Books)
- Review Informed Consent Forms (ICF); may author a global or regional ICF template
- Preparation of site and CRA training materials; may present information
- Country/site selection activities as requested
- Collaboration with Clinical Operations for budget preparation, CRO scope, etc. (i.e., review and provide feedback on activities/instructions/deliverables related to study data, IVRS, central labs, patient reported outcomes)
- Support study committee (e.g., DMC) activities (e.g., charters, meetings, presentations)
- Support Investigator Meeting and SIV planning/facilitation, including slide preparation
- Review clinical data for specific trends, mine data to support responses to HA or EC questions as requested
- Clinical review of study data (conduct clinical data review, communicate as necessary to resolve data queries, draft/update/review data review plans, support Clinical Research Physician in data review (generation of reports, action plans, trend identification), etc)
- Collaborate with study team members including: Clinical Operations, Data Management, Statistics, Drug Safety, IMSC, Regulatory Affairs, Translational Medicine and Project Management (set-up and/or lead meetings as appropriate)
- Regularly attend and actively participate in study team and other clinical meetings.
- Seek out and enact best practices with minimal instruction; contribute to process improvement.
- Actively seek and receive coaching/mentoring; may provide guidance to junior members of team.
- Contribute to preparations for external/stakeholder meetings (e.g., IMs, Governance)
- May present data/information to external investigators or study staff (e.g., SIV presentations)
- Provide regular and timely updates to manager
- Identify & escalate current/future issues; may propose solutions
- Set own priorities with moderate guidance from manager
- May support program level activities as requested
- Knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA & safety profile)
- Knowledge of the establishment and operation of data monitoring committees, 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.