Senior Manager, eCOA Management at Bristol-Myers Squibb
Princeton, NJ 08540
About the Job
Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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. Read more: careers.bms.com/working-with-us.Senior Manager, eCOA (Electronic Clinical Outcome Assessment) ManagementDivision: Research and Development (R&D), Global Development Operations (GDO), Global Data Management and Centralized Monitoring (GDM)Functional Area DescriptionGlobal Data Management (GDM) is responsible for clinical trial data acquisition, data management and review, and medical coding for trials across the BMS R&D portfolio.Position SummaryThe Senior Manager, eCOA Management role is essential to the study-level operationalization of the eCOA capability for BMS clinical trials, directly contributing to the BMS R&D pipeline. This role reports to the Associate Director, eCOA Management within GDM and is a full-time, office-based position with flexibility to work from home up to 50% of the time.Position Responsibilities
• Provide leadership for the operationalization of eCOA instruments for clinical trials, facilitating the end-to-end process, and working with clinical study teams and vendors to meet study requirements. Handle complex and high-priority studies.
• Work with eCOA vendors to ensure eCOA development is planned and executed effectively, both for initial deployment and post-production updates, ensuring timely delivery and issue resolution.
• Collaborate with stakeholders to ensure contracts, licenses, and translations are executed for timely eCOA delivery.
• Review and coordinate study-level eCOA process documents with study team members.
• Oversee eCOA development and testing activities, ensuring requirements are well-defined and met.
• Resolve eCOA issues during study conduct in collaboration with study team members and vendors.
• Ensure effective quality oversight and management of external partners performing eCOA activities on behalf of BMS.
• Manage work assignments to ensure timely delivery.
• Identify and resolve issues that may negatively impact the operationalization of eCOA tools, using collaborative strategies, and escalate issues to leadership when necessary.
• Follow procedural documents and participate in reviewing and updating them to reflect industry standards and regulatory requirements.
• Train and mentor newer team members on key activities and processes.
• Actively participate in and/or lead continuous improvement activities.
• Support preparations and follow-up actions related to Health Authority inspections and internal audits.
• Develop strong and productive working relationships with key stakeholders throughout GDM, GDO, and BMS, with the ability to think strategically across a broad portfolio.
• Represent the Company in interactions with key external partners as part of any committee or industry group relating to database development.Degree Requirements
• Bachelor's degree required.Experience Requirements
• At least 5 years of relevant industry and clinical trial experience, including specific experience with eCOA technologies, instruments, and end-to-end operationalization of eCOA.Key Competency Requirements
• Solid understanding of the drug development process with proven expertise in clinical trial start-up/execution and eCOA operationalization in a global arena.
• Strong technical expertise in eCOA processes, instruments, and clinical data acquisition/integration.
• Knowledge of industry-leading tools and emerging technologies supporting eCOA.
• Strong knowledge of GCP/ICH guidelines.
• Experience with reviewing technical documents, writing documents, and applying Systems Development LifeCycle (SDLC) and system validation principles.
• Demonstrated partnership across various collaborative forums and with external partners.
• Diverse technical expertise to interface with global development and business partners (medical, development, commercial, regulatory, quality).
• Ability to self-start, be solution-oriented, collaborate effectively with stakeholders, drive activities to completion, and be accountable for results.
• Potential need for periodic travel, (5%) as needed. 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 CareersWith 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.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to
• Provide leadership for the operationalization of eCOA instruments for clinical trials, facilitating the end-to-end process, and working with clinical study teams and vendors to meet study requirements. Handle complex and high-priority studies.
• Work with eCOA vendors to ensure eCOA development is planned and executed effectively, both for initial deployment and post-production updates, ensuring timely delivery and issue resolution.
• Collaborate with stakeholders to ensure contracts, licenses, and translations are executed for timely eCOA delivery.
• Review and coordinate study-level eCOA process documents with study team members.
• Oversee eCOA development and testing activities, ensuring requirements are well-defined and met.
• Resolve eCOA issues during study conduct in collaboration with study team members and vendors.
• Ensure effective quality oversight and management of external partners performing eCOA activities on behalf of BMS.
• Manage work assignments to ensure timely delivery.
• Identify and resolve issues that may negatively impact the operationalization of eCOA tools, using collaborative strategies, and escalate issues to leadership when necessary.
• Follow procedural documents and participate in reviewing and updating them to reflect industry standards and regulatory requirements.
• Train and mentor newer team members on key activities and processes.
• Actively participate in and/or lead continuous improvement activities.
• Support preparations and follow-up actions related to Health Authority inspections and internal audits.
• Develop strong and productive working relationships with key stakeholders throughout GDM, GDO, and BMS, with the ability to think strategically across a broad portfolio.
• Represent the Company in interactions with key external partners as part of any committee or industry group relating to database development.Degree Requirements
• Bachelor's degree required.Experience Requirements
• At least 5 years of relevant industry and clinical trial experience, including specific experience with eCOA technologies, instruments, and end-to-end operationalization of eCOA.Key Competency Requirements
• Solid understanding of the drug development process with proven expertise in clinical trial start-up/execution and eCOA operationalization in a global arena.
• Strong technical expertise in eCOA processes, instruments, and clinical data acquisition/integration.
• Knowledge of industry-leading tools and emerging technologies supporting eCOA.
• Strong knowledge of GCP/ICH guidelines.
• Experience with reviewing technical documents, writing documents, and applying Systems Development LifeCycle (SDLC) and system validation principles.
• Demonstrated partnership across various collaborative forums and with external partners.
• Diverse technical expertise to interface with global development and business partners (medical, development, commercial, regulatory, quality).
• Ability to self-start, be solution-oriented, collaborate effectively with stakeholders, drive activities to completion, and be accountable for results.
• Potential need for periodic travel, (5%) as needed. 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 CareersWith 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.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to
adastaffingsupport@bms.com
. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.SummaryLocation: Princeton LVL - NJ; Madison - Giralda - NJ - USType: Full time 