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Senior EDC Database Developer

Job ID : 15465

Job Title : Senior EDC Database Developer

Location : Berkeley Heights, NJ

Company Name : Bristol Myers Squibb Company

Industry : Information Technology

Salary : $66,000 - $111,000  per year

Job Type : Fulltime

Posted on: 2020-09-09

Required Skills : Medidata Rave, PMP Certification, SDLC, Communication Skills

Benefits : No benefits are available

Responsibilities include:

  • The 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 the development and deployment of study databases.
  • Identifying and resolving issues that 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, GCO, 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 Managers may also be responsible for managing employees and/or Functional Service Providers - Reviewing deliverables and timelines, providing ongoing feedback and performance review, empowering 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. Project management certification (e.g. PMP) is desirable.
  • At least 5 years of database development experience in Rave.
  • 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.

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