What are the responsibilities and job description for the Senior Manager, Clinical Data Management position at Bristol-Myers Squibb?
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
Senior Manager, Clinical Data Management
SUMMARY:
We are seeking a Senior Manager, Clinical Data Management who will be responsible for providing leadership in data management within the study team to align and drive data collection requirements for complex clinical development projects. This role will plan, coordinate and deliver complete, high quality and reliable clinical trial data.
DUTIES AND RESPONSIBILITIES:
- Provide clinical data management leadership within the study team to align and drive data collection requirements for complex clinical development projects.
- Plan, coordinate and deliver complete, high quality and reliable clinical trial data.
- Responsible for end-to-end clinical data management activities and serve as a primary point of contact for internal and external study team members.
- Provide strong project oversight over third party vendor for data management deliverables.
- Gather content and integration requirements for EDC and engage in close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway).
- Enforce data standard conventions and quality expectations for clinical data per defined processes.
- Author and review DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization.
- Chair Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness.
- Represent Data Management on cross-functional project team and submission Team.
- Lead or support the Health Authority inspection and audit.
- Provide coaching and quality oversight to junior Data Management Leads.
- Act as core member of the study team and provide FSP/CRO/Vendor oversight for end-to-end Data Management activities.
- Manage data currency throughout the trial, and monitor DM deliverables according to the Service Level Agreement (SLA).
- Provide relevant support and input to continuous improvement activities within clinical data management, and provide support for CAPA implementation as required.
MINIMUM REQUIREMENTS:
- Bachelor's degree or foreign equivalent degree in Bioanalytical Sciences, Biotechnology, Biology, Microbiology, Statistics, Biostatistics or a related field, and five (5) years of related work experience.
REQUIRED SKILLS:
- Medidata RAVE;
- Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management;
- EDC systems;
- Project management;
- Metrics analysis and reporting methodologies;
- Knowledge of Submission requirements for New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA).
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
Senior Manager, Clinical Data Management
SUMMARY:
We are seeking a Senior Manager, Clinical Data Management who will be responsible for providing leadership in data management within the study team to align and drive data collection requirements for complex clinical development projects. This role will plan, coordinate and deliver complete, high quality and reliable clinical trial data.
DUTIES AND RESPONSIBILITIES:
- Provide clinical data management leadership within the study team to align and drive data collection requirements for complex clinical development projects.
- Plan, coordinate and deliver complete, high quality and reliable clinical trial data.
- Responsible for end-to-end clinical data management activities and serve as a primary point of contact for internal and external study team members.
- Provide strong project oversight over third party vendor for data management deliverables.
- Gather content and integration requirements for EDC and engage in close collaboration with partners supporting other data collection systems (eCOA, External Data, Safety Gateway).
- Enforce data standard conventions and quality expectations for clinical data per defined processes.
- Author and review DM related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization.
- Chair Data Quality Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness.
- Represent Data Management on cross-functional project team and submission Team.
- Lead or support the Health Authority inspection and audit.
- Provide coaching and quality oversight to junior Data Management Leads.
- Act as core member of the study team and provide FSP/CRO/Vendor oversight for end-to-end Data Management activities.
- Manage data currency throughout the trial, and monitor DM deliverables according to the Service Level Agreement (SLA).
- Provide relevant support and input to continuous improvement activities within clinical data management, and provide support for CAPA implementation as required.
MINIMUM REQUIREMENTS:
- Bachelor's degree or foreign equivalent degree in Bioanalytical Sciences, Biotechnology, Biology, Microbiology, Statistics, Biostatistics or a related field, and five (5) years of related work experience.
REQUIRED SKILLS:
- Medidata RAVE;
- Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management;
- EDC systems;
- Project management;
- Metrics analysis and reporting methodologies;
- Knowledge of Submission requirements for New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA).
