Bristol-Myers Squibb Company

Principle Database Developer

Location
Hopewell, NJ, US
Posted
Oct 28, 2018
Ref
R1509274
Required Education
Masters Degree/MBA
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
  • Extensive experience with the development and management of clinical databases (Phase 1- 4) in the Pharmaceutical industry using Clinical Data Management System(s) (i.e. Rave or Oracle Clinical)
    • Building of database structures / data entry forms using Rave
    • Programming of edit checks and derivations
    • Configuration Mapping for study integrations including: Safety Gateway, TSDV, Consolidated Clinical Views (CCVs), CTMS/Rave Configuration (SMILE).
    • Troubleshoots issues with EDC, working with the EDC vendor as needed
    • Serve as a primary technical point of contact for assigned studies & provide technical support during study execution and closure
    • Support protocol amendments and database enhancements by:
    • Making modifications/additions to database structures/data entry forms
    • Modifying/adding necessary edit checks and derivations
    • Updating any/all configuration mappings for study integrations that is impacted by the database changes
    • Developing a Test Migration Plan and performing all necessary testing in the eCRF Amendment process in Rave, including creating the test migration plan, performing the impact analysis & reconciliation of changes the database structures, new and existing production data before deploying the changes into Production.
  • Support the clinical data snapshot process & other database lock procedures.
  • Generates and maintains all required documentation, including CRF Annotations, ALS, approval forms & supporting configuration reports, in support of database build and maintenance
  • Helps ensure QC of deliverables related to study setup and maintenance in accordance with ICH-GCP, SOPs and BMS standards
  • Promotes teamwork within study & functional teams, shares experiences and best practices
  • Serve as a subject matter expert for study build/database development
  • Has practical experience with various software tools and technologies such as but not limited to PL SQL, C#, UNIX, SAS, JReview, MS Office Products, etc.
  • Knowledge of general clinical research and of the pharmaceutical industry.
  • Works collaboratively with Custom Function programmers, Data Management and multiple functional groups to complete programming tasks per agreed upon timelines.
  • Responsible for all related deliverables, addressing issues and meeting timelines.
  • Liaison with stakeholders such as clinical study team, data management, biometrics and IT during study execution, protocol amendments and study lock.
  • Liaising with business and study builders/database developers in India.
  • Liaising with Medidata.
  • Is a member of the study team, attends meetings, participates in discussions, uses an analytical approach to problem solving with a focus on quality deliverables.
  • May provide mentorship to peers.


Position Requirements:

  • 4 to 6 years database development experience in the pharmaceutical industry working with clinical trial data.
  • Bachelor's degree, preferably in computing or scientific discipline.
  • Clinical trial knowledge is required.
  • Medidata Rave Study Builder certification preferred with at least 3 years of hands-on experience building studies in Rave.
  • Experience or knowledge of Rave Safety Gateway, TSDV is a plus.
  • Thorough understanding of regulations, GCP, ICH Guidelines as they apply to creation and maintenance of clinical databases.
  • Practical experience with programming using Visual Basic, APEX, PL SQL, XML, SAS, Java preferred.
  • Excellent communication skills, organized and ability to lead tasks from concept to delivery.