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Overview
Working with Us
Challenging. Meaningful. Life-changing. Bristol Myers Squibb offers work that goes beyond the ordinary. You will collaborate with high-achieving teams on activities ranging from optimizing production to breakthroughs in cell therapy, transforming lives of patients and the careers of those who contribute. We support growth and provide opportunities on a large scale and scope.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer competitive benefits, services and programs to help employees pursue their goals both at work and in personal life.
Position Summary The Senior Manager, Clinical Data Management is a leadership role essential to the sustainability and success of the BMS R&D pipeline. This role may report into Director, Clinical Data Management or Associate Director, Clinical Data Management. This position is office-based in BMS New Jersey locations.
Position Responsibilities
Project Management and Leadership: Provide clinical data management leadership within the study team to align on data collection requirements for one or more complex clinical development projects.
Coordinate and deliver complete, high-quality, reliable clinical trial data in a timely manner for assigned projects.
Manage end-to-end DM activities and serve as primary contact for internal and external study team members.
Oversee third-party data management deliverables with quality and project oversight.
Lead content gathering and integration requirements for EDC and collaborate with partners supporting other data collection systems; enforce data standards and quality for clinical data.
Author and/or review study documents to ensure quality and standardization (e.g., Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines).
Chair Data Quality Review meetings with cross-functional team members to ensure data currency, quality and completeness.
Represent DM on cross-functional project teams and submission teams.
Lead or support Health Authority inspections and audits.
Provide coaching and quality oversight of junior Data Management Leads.
FSP/CRO/Vendor Oversight: Act as a core member of the study team and provide oversight for end-to-end DM activities, manage data currency throughout the trial, and monitor DM deliverables according to the SLA.
Continuous Improvement Initiatives: Support continuous improvement activities within clinical data management and assist with CAPA implementation as required.
Degree / Experience Requirements
Bachelor’s Degree required; advanced degree preferred.
At least 5 years of relevant industry experience. Project management certification (e.g., PMP) desirable.
Key Competency Requirements
Ability to work collaboratively on multidisciplinary project teams and develop productive relationships with external vendors.
Solid knowledge of Clinical Drug Development Process, FDA/ICH guidelines and data management best practices.
Strong knowledge and experience with EDC systems (Medidata RAVE preferred); proficient in Microsoft Office; aware of industry trends and technologies supporting data collection.
Strong project management skills; proficient in metrics analysis and reporting methodologies.
Excellent oral and written communication; able to communicate effectively with senior management and cross-functional teams.
Knowledge of submission requirements (e.g., NDA/BLA/MAA).
Travel Required: 5-10% for Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed).
Additional Information If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers: With Transforming patients’ lives through science as our guiding vision, every BMS employee contributes to work that goes beyond ordinary and supports a culture of inclusion and integrity.
On-site Protocol and Accessibility BMS has an occupancy structure to determine where an employee conducts their work, including site-essential, site-by-design, field-based, and remote-by-design roles. The assigned occupancy type depends on role responsibilities. BMS is committed to accessibility and reasonable accommodations during recruitment and employment. For accommodation requests, contact adastaffingsupport@bms.com. Please visit careers.bms.com/eeo-accessibility for our Equal Employment Opportunity statement.
BMS emphasizes employee well-being. The company supports vaccination efforts and boosters where applicable.
We will consider qualified applicants with arrest and conviction records in compliance with applicable laws.
Data privacy: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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Challenging. Meaningful. Life-changing. Bristol Myers Squibb offers work that goes beyond the ordinary. You will collaborate with high-achieving teams on activities ranging from optimizing production to breakthroughs in cell therapy, transforming lives of patients and the careers of those who contribute. We support growth and provide opportunities on a large scale and scope.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer competitive benefits, services and programs to help employees pursue their goals both at work and in personal life.
Position Summary The Senior Manager, Clinical Data Management is a leadership role essential to the sustainability and success of the BMS R&D pipeline. This role may report into Director, Clinical Data Management or Associate Director, Clinical Data Management. This position is office-based in BMS New Jersey locations.
Position Responsibilities
Project Management and Leadership: Provide clinical data management leadership within the study team to align on data collection requirements for one or more complex clinical development projects.
Coordinate and deliver complete, high-quality, reliable clinical trial data in a timely manner for assigned projects.
Manage end-to-end DM activities and serve as primary contact for internal and external study team members.
Oversee third-party data management deliverables with quality and project oversight.
Lead content gathering and integration requirements for EDC and collaborate with partners supporting other data collection systems; enforce data standards and quality for clinical data.
Author and/or review study documents to ensure quality and standardization (e.g., Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines).
Chair Data Quality Review meetings with cross-functional team members to ensure data currency, quality and completeness.
Represent DM on cross-functional project teams and submission teams.
Lead or support Health Authority inspections and audits.
Provide coaching and quality oversight of junior Data Management Leads.
FSP/CRO/Vendor Oversight: Act as a core member of the study team and provide oversight for end-to-end DM activities, manage data currency throughout the trial, and monitor DM deliverables according to the SLA.
Continuous Improvement Initiatives: Support continuous improvement activities within clinical data management and assist with CAPA implementation as required.
Degree / Experience Requirements
Bachelor’s Degree required; advanced degree preferred.
At least 5 years of relevant industry experience. Project management certification (e.g., PMP) desirable.
Key Competency Requirements
Ability to work collaboratively on multidisciplinary project teams and develop productive relationships with external vendors.
Solid knowledge of Clinical Drug Development Process, FDA/ICH guidelines and data management best practices.
Strong knowledge and experience with EDC systems (Medidata RAVE preferred); proficient in Microsoft Office; aware of industry trends and technologies supporting data collection.
Strong project management skills; proficient in metrics analysis and reporting methodologies.
Excellent oral and written communication; able to communicate effectively with senior management and cross-functional teams.
Knowledge of submission requirements (e.g., NDA/BLA/MAA).
Travel Required: 5-10% for Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed).
Additional Information If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers: With Transforming patients’ lives through science as our guiding vision, every BMS employee contributes to work that goes beyond ordinary and supports a culture of inclusion and integrity.
On-site Protocol and Accessibility BMS has an occupancy structure to determine where an employee conducts their work, including site-essential, site-by-design, field-based, and remote-by-design roles. The assigned occupancy type depends on role responsibilities. BMS is committed to accessibility and reasonable accommodations during recruitment and employment. For accommodation requests, contact adastaffingsupport@bms.com. Please visit careers.bms.com/eeo-accessibility for our Equal Employment Opportunity statement.
BMS emphasizes employee well-being. The company supports vaccination efforts and boosters where applicable.
We will consider qualified applicants with arrest and conviction records in compliance with applicable laws.
Data privacy: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
#J-18808-Ljbffr