Bristol Myers Squibb
Pharmaceutical
SeniorManager,ClinicalDataStandards&ReportingEngineer
“Senior Manager, Clinical Data Standards & Reporting Engineer at Bristol Myers Squibb. Skills: Clinical Data Standards, Reporting, CDISC, SDTM. Serve as primary point of contact. Guide study teams in interpreting standards”
What You'll Achieve.
ensure compliant submissions; success of the BMS R&D pipeline; ensure compliance to regulatory needs; alignment to industry standards; ensure consistency in understanding and implementation across a project; ensuring timely and compliant implementation of approved standards
Industry & Context.
query resolution
What They're Looking For.
Must Have
Bachelor’s degree required, 8 to 11 years of relevant industry experience with clinical trials, Experience in Industry Standards (e.g. CDISC), working knowledge of the overall pharmaceutical development process, working knowledge of SDTM, Knowledge of requirements of define.xml, Experience in CRF design, query resolution, general data validation, Good communication skills, high ability to communicate standards related issues, options, their impact to project teams, within department, Ability to work effectively in a team environment
Nice to Have
experience with clinical data standards as a focus, Experience with Medidata Rave (EDC), Metadata Repository (MDR), SDTM programming, Experience interpreting Health Authority regulations, compliance background, creation of data mapping specifications, annotated CRFs
What You'll Do.
Serve as primary point of contact
Guide study teams in interpreting standards
Ensure compliance to regulatory needs
Align to industry standards
Participate in study team meetings
Act as consulting resource
Communicate and reinforce content
Process clinical standard change requests
Contribute to development of global standards
Create and maintain standard metadata libraries
Create and maintain submission standards
Support complex implementation scenarios
Support harmonization efforts
Participate in development and maintenance
Act as expert on industry standards
Evaluate and process change requests
Support standards governance framework
Support documentation and rollout
Review and implement technical change requests
Act as liaison between governance framework
Support standards governance committees
Develop training materials
Provide training on standards
Participate in strategic initiatives
Share new industry standards
Serve as technical SME for systems
Coach CROs and vendors
Work with standards management systems
Participate in identification
Develop or maintain clinical data transformation tools
How You'll Work.
Team & Collaboration
Serve as the primary point of contact for study teams members; Participate in relevant study team meetings; Act as a consulting resource for study team members; Communicate and reinforce content and interpretation of BMS standards to project and study teams; Support harmonization efforts across Clinical, Biometrics, Data Management, and Regulatory functions; Act as a liaison between the standards governance framework and project teams; Support standards governance committees, partnering with functional areas; Ability to work effectively in a team environment with medical personnel, study managers, project managers, clinical monitors, data managers, programmers, and statisticians
Communication Scope
Good communication skills; high ability to communicate standards related issues, options, and their impact to project teams and within department
Process & Methodology
Develop a recommendation and implementation plan for the standards end-to-end
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