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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. Read more: careers.bms.com/working-with-us.

The Manager, eCOA Management is essential to the study-level operationalization of the eCOA capability and contributes directly to the success of the BMS R&D pipeline. This role is responsible for the effective technical implementation (form design, specifications development, UAT, etc.) of electronic Clinical Outcomes Assessments (eCOA).

This role reports to the Associate Director, eCOA Management within GDM&CM and is a full-time, office-based position.

Position Responsibilities:

• Providing operational oversight of eCOA instruments for clinical trials, providing technical expertise to clinical study teams and working with them to understand and implement study-specific eCOA designs and requirements.

• Liaise with eCOA vendors to ensure eCOA study requirements are clearly understood and documented.

• Reviewing documents required for the study-level eCOA process (e.g., requirement specifications, UAT documentation) and coordinating reviews with clinical study team members as needed.

• Owning the eCOA UAT activities ensuring successful planning and execution against timelines.

• If eCOA UAT activities are being supported by a vendor, providing oversight for the eCOA UAT vendor to ensure study-level eCOA UAT is planned effectively and executed on time with quality UAT deliverables.

• Managing work assignments to ensure timely delivery.

• Identifying and resolving issues which may negatively impact delivery of work. Seeking support from leadership as needed.

• Following procedural documents when completing deliverables.

• Participating in continuous improvement activities as required.

• Supporting preparations and follow-up actions related to Health Authority inspections and internal audits for assigned studies.

• Developing strong and productive working relationships with key stakeholders throughout GDMCM, GDO, and BMS.

Experience Requirements:

• Bachelors degree in relevant field

• At least 4 years of relevant industry and clinical trial experience including at least 3 years of specific experience with eCOA capabilities, technologies, and instruments.

• Strong technical expertise in the area of eCOA processes, instruments, and data acquisition.

• Good understanding of the drug development process with proven expertise in clinical trial start-up/execution and eCOA management in a global arena.

• Solid knowledge of industry leading tools and well versed in industry trends and emerging technologies supporting eCOA.

• Good knowledge of GCP/ICH guidelines.

• Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.

• Demonstrated partnership across collaborative forums.

• Demonstrated ability to self-start, be solution-oriented, collaborate effectively with stakeholders, and be accountable for results.

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 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
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.