Senior Manager, EDC (Electronic Data Capture) Management, (Global Library Developer/Librarian) (R1557530-en-us)
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.
The Senior Manager, EDC Management contributes directly to the success of the BMS R&D pipeline is responsible for the effective development, management, and implementation of the EDC system at a global level. This role reports to the Director, EDC Management or Associate Director, EDC Management within GDM&CM and is a full-time, office-based position or fully remote.
Ensuring the EDC system is being developed and managed at a global level for effective use for study databases. Depending on the area of focus, this can include one or more of the following:
Developing and implementing the global library strategy and structures.
Building, maintaining and documenting the Medidata Rave global library standard objects (e.g., eCRF forms, edit checks) in order to facilitate the creation of study level databases to collect clinical trial data.
Working with Clinical Data Standards, Data Managers, and EDC Database Developers to implement new or modified global library objects and to develop appropriate timelines for delivery of the global library objects.
Ensuring the EDC internal module connections (e.g., Safety Gateway, TSDV) and external system integrations (e.g., with the Clinical Trial Management System and Payment systems) are configured and implemented effectively.
Working closely with EDC providers and internal stakeholders to ensure the systems are meeting BMS expectations and enhancement requirements are being appropriately considered in the providers’ roadmap.
Managing work assignments to ensure timely delivery.
Identifying and resolving issues which may negatively impact delivery of work, using collaborative strategies to reach resolution. Escalating issues to leadership appropriately.
Following procedural documents and participating in reviewing and updating of documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes.
Contributing to the development and application of smart systems and optimal approaches to support the collection of data.
Actively participating in and/or leading continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability.
Supporting preparations and follow-up actions related to Health Authority inspections and internal audits.
Liaising with and reviewing work delivered by external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing activities on behalf of BMS.
Developing strong and productive working relationships with key stakeholders throughout GDMCM, 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 global library development.
Bachelor’s degree required.
At least 5 years of relevant industry and clinical trial experience and a successful track record of leading through influence, working across complex, global organizational matrices.
At least 5 years of clinical database developer experience in Rave with experience in global library development and development of standard data collection objects.
Strong understanding of the drug development process with proven expertise in clinical trial execution and global library development/clinical database development in a global arena.
Strong knowledge of industry leading EDC tools (e.g. Medidata Rave, Oracle, etc.) and well versed in industry trends and emerging technologies supporting data collection.
Strong knowledge of GCP/ICH guidelines.
Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
An understanding of database and dictionary structures (e.g. MedDRA, WHODrug).
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.
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.
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