Bristol Myers Squibb
Pharmaceuticals
AssociateDirector,ClinicalDataManagement
“Associate Director, Clinical Data Management at Bristol Myers Squibb. Skills: Clinical Data Management, Program Management, Line Management, Project Management, Vendor Oversight. Provide oversight of a program within the organization. Establish a governance framework for a program or asset”
What You'll Achieve.
Ensuring that the studies within the program are delivered per corporate goals and objectives; Deliver complete, high quality and reliable clinical trial data in a timely manner
Industry & Context.
Solution oriented mindset; Ability to drive change; Resolve complex issues and proactively develop solutions; Leveraging technical/functional expertise to develop solutions; Using clear communications and collaborative strategies to drive to resolution
Ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed (for field-based and remote-by-design roles)
What They're Looking For.
Must Have
Bachelor's Degree, At least 7 years of relevant industry experience, Knowledge of Clinical Drug Development Process, Knowledge of regulatory and ICH guidelines (e.g. EMEA, FDA), Knowledge of industry standard practices regarding data management, Knowledge and experience of EDC systems, Demonstrated knowledge of Microsoft Office skills, Well versed in industry trends and emerging technologies supporting data collection, Expertise in metrics analysis and reporting methodologies, Solid knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)]
Nice to Have
Advanced degree preferred, Project management certification (e.g. PMP), Experience in managing late phase studies and portfolio for Data Management is highly preferred, Medidata RAVE preferred
What You'll Do.
Provide oversight of a program within the organization
Establish a governance framework for a program or asset
Develop productive working relationships with cross functional stakeholders
Attend program level strategic meetings
Set program level data collection and review standards
Line management responsibility of Data Management Leads
Manage resource assignments
Forecast future resource needs
Assign resources to initiatives
Coach and mentor staff
Promote a workplace culture that values diversity of thought
creates accountability
supports effective decision making
and provides opportunities to grow
high quality and reliable clinical trial data
Provide clinical data management leadership within the study team
Responsible for end-to-end clinical data management activities
Provide quality and project oversight over third party vendor responsible for data management deliverables
Gather content and integration requirements for EDC and other data collection systems
Enforce data standard conventions and quality expectations
review/revise DM related study plans
Participate in Data Quality Review meetings
Represent DM on cross-functional project teams
portfolio review meetings & Submission Teams
Lead or support Health Authority inspections and audits
Provide FSP/CRO/Vendor oversight for end-to-end Data Management activities
Manage data currency throughout the trial
Monitor DM deliverables according to the Service Level Agreement (SLA)
Support change management initiatives
Evaluate and recommend new technologies and systems for improved data management functionality
Mentor new or existing team members
Lead CAPA management activities
Resolve complex issues and proactively develop solutions
Author procedural documents (SOPs
How You'll Work.
Team & Collaboration
Develop productive working relationships with cross functional stakeholders; Attend program level strategic meetings; Collaborate on multi-disciplinary project teams; Communicate effectively with senior management and cross-functional teams; Represent DM on cross-functional project teams, portfolio review meetings & Submission Teams
Communication Scope
Excellent oral and written communication skills; Communicate effectively with senior management and cross-functional teams
Process & Methodology
Program Management, Project Management, Oversight of studies and Data Management Leads, Establish governance framework, Risk monitoring and mitigation, Planning, coordination, and delivery of clinical trial data, End-to-end clinical data management activities, Oversight over third party vendors, Manage data currency, Monitor DM deliverables, Lead CAPA management activities
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