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.
Senior Manager, eCOA Management
- Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Electronic Clinical Outcome Assessment (eCOA) Lead (D6)
Research & Development/Global Development Operations/Global Data Management & Central Monitoring
The Senior Manager in eCOA Management resides in the Global Data Management & Central Monitoring (GDM&CM) organization within Global Development Operations.
The Senior Manager 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 summary) 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
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 the resources to pursue their goals, both at work and in their personal lives.
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.