Bristol Myers Squibb
Senior Manager, Clinical Data Management
Bristol Myers Squibb, Madison, New Jersey, us, 07940
Overview
Senior Manager, Clinical Data Management – Bristol Myers Squibb. This role leads clinical data management activities within one or more complex clinical development projects and may report to the Director or Associate Director, Clinical Data Management. This is an office-based role in New Jersey. Position Responsibilities
Project Management and Leadership: provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects Plan, coordinate, and deliver complete, high quality and reliable clinical trial data in a timely manner for assigned projects Oversee end-to-end clinical data management activities and serve as a primary point of contact for internal and external study team members Provide quality and project oversight of third-party vendors responsible for data management deliverables Lead content and integration requirements for EDC and collaborate 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 (Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines) to ensure quality and standardization Chair Data Quality Review meetings with cross-functional study team members to ensure ongoing data currency, quality, and completeness Represent DM on cross-functional 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
May 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 SLA Continuous Improvement
Contribute to continuous improvement activities within clinical data management Support 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) is desirable Key Competency Requirements
Ability to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines, and industry data management practices Experience with EDC systems (Medidata RAVE preferred); proficient in Microsoft Office; aware of industry trends and data collection technologies Strong project management skills; adept at metrics analysis and reporting Excellent oral and written communication; able to communicate with senior management and cross-functional teams Knowledge of submission requirements (NDA/BLA/MAA) Travel
5-10% required (Industry Conferences, Investigator Meetings, Regulatory Inspections as needed) Compensation and Benefits
The starting compensation range for this role is listed by location for full-time employment. Additional incentive cash and stock opportunities may be available based on eligibility. Benefits vary by location and may include medical, dental, vision, 401(k), and other programs described on the careers site. Working with Us
Challenging. Meaningful. Life-changing. Bristol Myers Squibb offers opportunities to grow and thrive alongside high-achieving teams, with a culture rooted in our values of passion, innovation, urgency, accountability, inclusion and integrity. Uniquely Interesting Work, Life-changing Careers. Transforming patients’ lives through science is our shared vision. Legal and Accessibility
BMS is committed to equal employment opportunity. Applicants may request reasonable accommodations during the recruitment process. For inquiries, contact adastaffingsupport@bms.com. Details on EEO and accessibility are available at careers.bms.com/eeo-accessibility.
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Senior Manager, Clinical Data Management – Bristol Myers Squibb. This role leads clinical data management activities within one or more complex clinical development projects and may report to the Director or Associate Director, Clinical Data Management. This is an office-based role in New Jersey. Position Responsibilities
Project Management and Leadership: provides clinical data management leadership within the study team to align on and drive data collection requirements for one or more complex clinical development projects Plan, coordinate, and deliver complete, high quality and reliable clinical trial data in a timely manner for assigned projects Oversee end-to-end clinical data management activities and serve as a primary point of contact for internal and external study team members Provide quality and project oversight of third-party vendors responsible for data management deliverables Lead content and integration requirements for EDC and collaborate 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 (Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines) to ensure quality and standardization Chair Data Quality Review meetings with cross-functional study team members to ensure ongoing data currency, quality, and completeness Represent DM on cross-functional 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
May 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 SLA Continuous Improvement
Contribute to continuous improvement activities within clinical data management Support 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) is desirable Key Competency Requirements
Ability to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines, and industry data management practices Experience with EDC systems (Medidata RAVE preferred); proficient in Microsoft Office; aware of industry trends and data collection technologies Strong project management skills; adept at metrics analysis and reporting Excellent oral and written communication; able to communicate with senior management and cross-functional teams Knowledge of submission requirements (NDA/BLA/MAA) Travel
5-10% required (Industry Conferences, Investigator Meetings, Regulatory Inspections as needed) Compensation and Benefits
The starting compensation range for this role is listed by location for full-time employment. Additional incentive cash and stock opportunities may be available based on eligibility. Benefits vary by location and may include medical, dental, vision, 401(k), and other programs described on the careers site. Working with Us
Challenging. Meaningful. Life-changing. Bristol Myers Squibb offers opportunities to grow and thrive alongside high-achieving teams, with a culture rooted in our values of passion, innovation, urgency, accountability, inclusion and integrity. Uniquely Interesting Work, Life-changing Careers. Transforming patients’ lives through science is our shared vision. Legal and Accessibility
BMS is committed to equal employment opportunity. Applicants may request reasonable accommodations during the recruitment process. For inquiries, contact adastaffingsupport@bms.com. Details on EEO and accessibility are available at careers.bms.com/eeo-accessibility.
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