Senior Manager, EDC Database Development
Bristol-Myers Squibb
Braine L'Alleud, BE
2 dagen geleden

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. Summary The Senior EDC 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).

This is a full-time, office-based position located in either Central New Jersey, USA, or Braine-l’Allaud, Belgium or Boudry, Switzerland Responsibilities 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.

Experience and Expertise Required Bachelor’s degree required with an advanced degree preferred. At least 5 years of relevant industry experience.

Strong project management skills : Project management certification (e.g. PMP) is desirable. At least 5 years of database development experience in Rave.

Strong knowledge of clinical study design. Experience with CDISC standards including CDASH and SDTM is desirable. Global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices.

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.

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.

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