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Senior Manager, EDC Clinical Database Developer, Boudry, Nebraska

CategoryClinical Dev
Job typeFull-Time

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.

Celgene (a wholly owned subsidiary of Bristol-Myers Squibb) is a global biopharmaceutical company committed to changing the course of human health through bold pursuits in science, life-enhancing therapies, and a promise to always put patients first. At the core of that mission are the talented individuals who contribute their unique skill sets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we're looking for talented professionals like you to join our team

The Senior EDC Clinical Database Developer is a role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Associate Director - EDC Database Development Line Manager within the Global Data Management and Centralized Monitoring (GDMCM) function of Global Development Operations (GDO).

In this role, you will be:
  • Building, maintaining and deploying study databases to collect clinical trial data, including configuring custom integrations.
  • Managing work assignments to ensure timely delivery of study databases.
  • Working with Data Management to develop appropriate timelines for development and deployment of study databases.
  • Identifying and resolving issues which may negatively impact delivery of study databases. 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.
  • 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.
  • Liaising with and reviewing work delivered by external partners (e.g. Function Service Providers, CROs, technology providers, etc.) performing database development services 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 database development.
  • Some Senior Database Developers may also be responsible for mentoring/managing Functional Service Providers - Reviewing deliverables and timelines and holding staff to high quality performance and delivery.

Your Profile
  • Bachelor's degree required within Programming or Sciences
  • At least 5 years of database development experience in Rave
  • Strong knowledge of clinical study design
  • Proven project management skills
  • Immuno-Oncology therapeutic experience is highly desirable
  • Good understanding of the drug development process with proven expertise in clinical trial execution and data acquisition in a global arena
  • Strong knowledge of industry leading eCRF 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
  • Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks
  • Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team
  • Fluent in English - any other European language is a plus

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.
EmployerBristol-Myers Squibb

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