Senior Manager, eCOA Management

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Electronic Clinical Outcome Assessment (eCOA) Lead (D6)

Research & Development/Global Development Operations/Global Data Management & Central Monitoring

The eCOA Lead resides in the Global Data Management & Central Monitoring (GDM&CM) organization within Global Development Operations. 

The eCOA Lead is essential to the operationalization of the eCOA capability for BMS R&D clinical trials.  This role reports to the Associate Director, eCOA Management within GDM&CM.

This is an office-based position located in Central New Jersey, USA.

• Providing leadership for the operationalization of eCOA instruments for clinical trials, providing technical expertise to clinical study teams and working with them to understand study specific eCOA designs and requirements.
• Liaising 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 specification, UAT test plan, UAT test summar) and coordinating reviews with clinical study team members as needed.
• Providing oversight for eCOA UAT vendor to ensure study level eCOA UAT is planned for effectively and executed on time with quality UAT deliverables. 
• Coordinating with the eCOA Business Capability Team and eCOA Steering Committee members to understand eCOA book of work, eCOA capability release plans and roadmap, and technology/process improvement opportunities. 
• Identifying and resolving issues which may negatively impact operationalization of eCOA tools.  Escalating issues to leadership as needed.
• Following procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and easily followed.
• Actively participating in and/or leading continuous improvement activities.
• Developing strong and productive working relationships with key stakeholders throughout GDM&CM, 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.

Bachelor’s degree required

At least 5 years of relevant industry and clinical trial experience including specific experience with eCOA capabilities and instruments.

• Strong technical expertise in the area of eCOA and eCOA instruments.
• Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices.
• Good understanding of the drug development process with proven expertise in clinical trial execution and eCOA management in a global arena.
• Strong knowledge of industry leading tools and well versed in industry trends and emerging technologies supporting eCOA.
• Strong knowledge of GCP/ICH guidelines.
• Proven experience with reviewing technical documents, writing documents, and applying Systems Development LifeCycle (SDLC) and system validation principles.
• Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.
• Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.).
• Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team.

Periodic travel as needed

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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. 

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

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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