Clinical Database Developer is responsible for understanding and using BMS systems, processes and standards for planning, creation, testing, validation and documentation of all system components needed to support Phase 1 - 4 clinical trial data acquisition, management and storage.
Includes expert programming knowledge and delivery of clinical database entry forms, database structures, edit checks, derivations, integrations (web services, data load configurations, extract procedures and downstream mapping, transformations and management of CRO data), as well as the system based procedures for proper workflow and management of these objects and the data that flow through them. Occasional programming, testing and validation of releases and use and development of add on software for reporting, workflow, metrics quality control checks, and technical support of the infrastructure in place. Liaison with stakeholders such as Global Biometrics Sciences, BMS IT, and study teams needing support during study execution, protocol amendments and study lock.
- Project contact for business partners for all database development and programming tasks, for example those involved with the clinical database, derivations, edit checks, data integration (external data transformation, load and extraction), data extract views, web services and peripheral application integration.
- Responsible for all related deliverables, addressing issues and meeting timelines. Reviews CRFs, designs new clinical database structures in collaboration with the Global Librarian and ensures consistency, reusability and alignment with Global Standards throughout a project.
- Trains or ensures training exists for Database Development staff as appropriate.
- Provides leadership and direction for database development for multiple projects/therapeutic area(s) and/or functional area(s)
- Coordinates workload and mentors staff in functional and leadership competencies.
- May serve as a subject matter expert for one or more areas of database development, data integration or technology for entire organization.
- May lead one or more functional areas, for example, Database Development, External Data Integrations, Extract Transform Load, Global Librarian/Standards, Training, Documentation, SDTM mapping support, Patient Data Mart or other initiatives etc.
- Is experienced with data exchange with CRO ’s, third party vendors and or central labs, is familiar with other outsourcing/offshoring models and can effectively work with external partners to achieve goals.
- Coordinates and prioritizes workload and resource allocation for multiple projects in collaboration with business partners according to timelines. Identifies risk areas and possible improvements.
- Supports the design and review of CRFs, clinical databases including data entry screens, programming of edit checks, load configurations and conversions, QC checks, maintenance of global library objects, draft and final CRFs either directly or via oversight
- Is familiar with developing training materials, SOP ’s, operating manuals and Share Point sites
- Is familiar with masking and blinding concepts
- Is familiar with programming reports for Data Management, Reporting, general metrics or other stakeholders using SAS, Excel, Spotfire or other software against databases
- Expert knowledge in MS Office products and presentation software
- Has familiarity with various software tools and technologies such as but not limited to (Medidata Rave, Oracle Clinical, Toad, PL SQL, XML, Oracle 12g, sFTP, Filezilla, RWS, eLoader, Batch Uploader, Oracle APEX, SAS, JReivew, Informatica, Citrix, C#, Java, XSLT)
- Supports and maintains standard and reusable database objects within the Global Library, as applicable.
- Following BMS project management methodology, this individual may develop teams to create and implement strategies to meet current and future business needs (on occasion they may directly create and implement the strategy).
- Participates in or establishes effective communication channels with all business partners and aligns business partners, project team, and peers to deliver value-added results to the organization.
- Bachelor's degree with 5 years or Associates Degree with 8 years of clinical database development experience is required as well as extensive hands on experience with leading industry clinical data management tools such as Oracle Clinical and/or Rave.
- Experience managing projects, influencing team members and business partners with track record of delivering results in an environment with quickly changing priorities and timelines
- Ability to dhere to BMS best practices and global standards. Works closely with study team and communicates project timelines. Provide expert knowledge in database development and serves as a liaison between CDIT and GDSS on cross-functional projects.
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