Bristol Myers Squibb
Sr. Manager, eCOA Management
Bristol Myers Squibb, Princeton, New Jersey, us, 08543
Challenging. 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.The Senior Manager, eCOA Management role is essential to the study level operationalization of the eCOA capability for BMS clinical trials and directly contributes to the BMS R&D pipeline.This role reports to the Associate Director, eCOA Management within GDM and is a full-time, New Jersey office-based position with flexibility to work from home up to 50% of the time.Responsibilities:
Providing leadership for the operationalization of eCOA instruments for clinical trials, facilitating the end to end process, providing expertise to clinical study teams and working with them and vendors to implement eCOA to meet study requirements.Taking responsibility for more complex studies in the portfolio which may require additional expertise and/or high priority studies.Working with eCOA vendors to ensure eCOA development is planned effectively and executed according to plan, both for initial eCOA deployment and post production updates.Ensuring eCOA is delivered as expected to meet study timeline requirements and issues are effectively resolved.Working with other stakeholders to ensure contracts, licenses and translations are executed to enable timely eCOA delivery.Reviewing documents required for the study level eCOA process and coordinating reviews with study team members as needed.Overseeing eCOA development and testing activities, ensuring requirements are well defined and met.Working with study team members and vendors to ensure eCOA issues during study conduct are effectively resolved.Ensuring effective quality oversight and management of external partners performing eCOA activities on behalf of BMS.Managing work assignments to ensure timely delivery.Identifying and resolving issues which may negatively impact operationalization of eCOA tools, using collaborative strategies to reach resolution. Escalating issues to leadership appropriately.Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes.Training and/or mentoring newer team members on key activities and processes.Actively participating in and/or leading continuous improvement activities.Supporting preparations and follow-up actions related to Health Authority inspections and internal audits.Developing strong and productive working relationships with key stakeholders throughout GDM, GDO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.Representing the Company in interactions with key external partners as part of any committee or industry group relating to database development.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 Protocol
BMS 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.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: https://careers.bms.com/california-residents/Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.Company:
Bristol-Myers SquibbUpdated:
2024-09-09 03:57:52.354 UTCLocation:
Princeton-NJBristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
#J-18808-Ljbffr
Providing leadership for the operationalization of eCOA instruments for clinical trials, facilitating the end to end process, providing expertise to clinical study teams and working with them and vendors to implement eCOA to meet study requirements.Taking responsibility for more complex studies in the portfolio which may require additional expertise and/or high priority studies.Working with eCOA vendors to ensure eCOA development is planned effectively and executed according to plan, both for initial eCOA deployment and post production updates.Ensuring eCOA is delivered as expected to meet study timeline requirements and issues are effectively resolved.Working with other stakeholders to ensure contracts, licenses and translations are executed to enable timely eCOA delivery.Reviewing documents required for the study level eCOA process and coordinating reviews with study team members as needed.Overseeing eCOA development and testing activities, ensuring requirements are well defined and met.Working with study team members and vendors to ensure eCOA issues during study conduct are effectively resolved.Ensuring effective quality oversight and management of external partners performing eCOA activities on behalf of BMS.Managing work assignments to ensure timely delivery.Identifying and resolving issues which may negatively impact operationalization of eCOA tools, using collaborative strategies to reach resolution. Escalating issues to leadership appropriately.Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes.Training and/or mentoring newer team members on key activities and processes.Actively participating in and/or leading continuous improvement activities.Supporting preparations and follow-up actions related to Health Authority inspections and internal audits.Developing strong and productive working relationships with key stakeholders throughout GDM, GDO, and BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.Representing the Company in interactions with key external partners as part of any committee or industry group relating to database development.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 Protocol
BMS 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.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: https://careers.bms.com/california-residents/Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.Company:
Bristol-Myers SquibbUpdated:
2024-09-09 03:57:52.354 UTCLocation:
Princeton-NJBristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
#J-18808-Ljbffr