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 Manager, EDC Database Development contributes directly to the success of the BMS R&D pipeline is responsible for the effective development of study level EDC databases.
This role reports to the Associate Director, EDC Database Development within GDM&CM and is a full-time, office-based Position.Responsibilities include:
Experience and expertise required:
- Building, maintaining and deploying study databases to collect clinical trial data, including configuring study database internal module connections and external system integrations. Being responsible for initial study database development and changes required after initial deployment.
- Contributing to the development of appropriate timelines for development and deployment of study databases.
- Providing EDC technical expertise to Data Management and to the clinical study team members to support study decisions.
- 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.
- Actively participating in 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.
- Representing the Company in interactions with key external partners as part of any committee or industry group.
- Bachelor's degree required with an advanced degree preferred.
- At least 4 years of global clinical trial expertise with a focus on EDC database development.
- At least 3 years of clinical database development experience in Rave.
- Good understanding of the drug development process with proven expertise in clinical trial start-up/execution and EDC database development.
- Solid knowledge of industry leading EDC tools (e.g. Medidata Rave, Oracle/Inform, etc.) and well versed in industry trends and emerging technologies supporting data collection.
- Good knowledge of clinical study design.
- Strong knowledge of GCP/ICH guidelines.
- Technical expertise, technical writing ability, and proficiency in Systems Development LifeCycle (SDLC) principles.
- Understanding of database and dictionary structures (e.g. MedDRA, WHODrug).
- Experience with CDISC standards including CDASH and SDTM is desirable.
- You're looking for a dynamic and team-working environment !
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.