Bristol Myers Squibb
Healthcare
SeniorManager,GlobalClinicalScienceCardiovascular
“Senior Manager, Global Clinical Science - Cardiovascular at Bristol Myers Squibb. Skills: Clinical Science, Protocol design, Data review, Regulatory documents. Design clinical trial activities. Execute clinical trial activities”
Industry & Context.
Critical thinking; Problem-solving
Domestic travel, International travel
What They're Looking For.
Must Have
Degree in Life Sciences, Basic knowledge of GCP/ICH, Basic knowledge of drug development, Basic knowledge of study design, Basic knowledge of statistics, Basic knowledge of clinical operations, Ability to understand assigned protocol(s), Basic knowledge skills to support program-specific data review, Basic knowledge of trend identification, Intermediate medical writing skills, Intermediate medical terminology, Basic planning skills, Basic project management skills, Basic knowledge of disease area, Basic knowledge of compound, Basic knowledge of current clinical landscape, Basic knowledge of data monitoring committees, Basic knowledge of dose review teams, Basic knowledge of independent response adjudication committees, Intermediate critical thinking skills, Intermediate problem-solving skills, Intermediate skills in Microsoft Word, Intermediate skills in Microsoft Excel, Intermediate skills in Microsoft PowerPoint, Intermediate skills in data review tools
Nice to Have
MD, PhD, Pharm D, MS, RN or other scientific field preferred, Appropriate for new entrance to pharma, Post fellowship/ new to industry
What You'll Do.
Design clinical trial activities
Execute clinical trial activities
Work closely with clinical team members
Execute activities associated with conduct
Serve as Clinical Trial Lead
Lead trial level activities
Support trial level activities
Co-lead study team meetings
Collaborate with cross-functional study team members
Collaborate with external partners
Liaise with external partners
Provide updates to manager
Develop Protocol documents
Develop ICF documents
Present documents to governance committee
Present documents to development team meetings
Conduct literature review
Submit clinical documents to TMF
Develop site training materials
Develop CRA training materials
Present training materials at SIVs
Present training materials at Investigator meetings
Review clinical narratives
Monitor clinical data
Develop Data Review Plan
Ensure CRF design supports data collection
Submit clinical contributions to CSRs
Contribute to regulatory submission
How You'll Work.
Team & Collaboration
Clinical team members; Cross-functional study team members; External partners; KOLs
Communication Scope
Present documents; Present training materials
Process & Methodology
Planning, Project management
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