Director, Clinical Database Programming
About The Position
Roivant Sciences, Inc. has an opening for a Director Clinical Database Programming. This role involves maintaining responsibility for the technical aspects of database building and matrix design using Medidata RAVE, Oracle InForm, Veeva CDMS, or another EDC for development of Roivant global library or specific studies. The position requires providing expertise in finalizing build specifications with Roivant’s Lead Clinical Data Manager to effectively support data collection, review, and monitoring based on cross-functional and study-related goals and endpoints. The Director will oversee programming of custom functions and other edit checks to programmatically streamline collection of and validate clinical data as it is entered. They will also perform and validate any data migrations and/or post-production database changes needed after initial database go-live. Maintaining appropriate documentation of process adherence, in accordance with Roivant SOPs, is crucial. The role includes overseeing clinical database build timelines, in concert with the Lead Clinical Data Manager, Project Manager, and other critical study team members. Implementation and integration of clinical study products such as eConsent, eCOA applications, RTSM, etc., are key responsibilities. The Director will lead cross-functional teams in requirements for UAT and validation tasks related to EDC build, metrics report programming, and data listings. Supporting data management activities, including data cleaning, query resolution, data reconciliations, drafting of Data Management documentation, and coordination of database freeze/lock deliverables, is also part of the role. Additionally, the Director will support programming tasks associated with project-specific metrics reporting, working across the project team to ensure reports meet the needs of all internal and external stakeholders, and train internal and external stakeholders on clinical database functionality as needed.
Requirements
- Bachelor’s Degree in Biology, Chemistry, Physics, Computer Science, Information Technology, Biotechnology, and Bioinformatics, or a health-related field or foreign equivalent
- 8 years of progressively responsible experience with clinical data programming in the pharmaceutical, biotechnology, and/or diagnostics industry in an FDA-regulated environment
- Medidata RAVE build certification
- 5+ years experience working in Electronic Data Capture (EDC) systems, such as Oracle InForm, Veeva CDMS, IBM Clinical Development, Medrio, etc.
- 5+ years of experience implementing and integrating Medidata products (including randomization and trial supply management (RTSM), Coder, and Electronic Clinical Outcome Assessment (eCOA)
- 5+ years of experience performing data management for different phases of clinical trials on Oncology programs
- 7+ years of experience performing data management and/or database programming within the ICH and regulatory environment
Responsibilities
- Maintaining responsibility for the technical aspects of database building and matrix design using Medidata RAVE, Oracle InForm, Veeva CDMS, or another EDC for development of Roivant global library or specific studies
- Providing expertise in finalizing build specifications with Roivant’s Lead Clinical Data Manager to effectively support data collection, review, and monitoring based on cross-functional and study-related goals and endpoints
- Overseeing programming of custom functions and other edit checks to programmatically streamline collection of and validate clinical data as it is entered
- Performing and validating any data migrations and/or post-production database changes needed after initial database go-live
- Maintaining appropriate documentation of process adherence, in accordance with Roivant SOPs
- Overseeing clinical database build timelines, in concert with the Lead Clinical Data Manager, Project Manager, and other critical study team members
- Implementing and integrating clinical study products such as eConsent, eCOA applications, RTSM, etc.
- Leading cross-functional team in requirements for UAT and validation tasks related to EDC build, metrics report programming, and data listings
- Supporting data management activities, including data cleaning, query resolution, data reconciliations, drafting of Data Management documentation, and coordination of database freeze/lock deliverables
- Supporting programming tasks associated with project-specific metrics reporting, working across the project team to ensure reports meet the needs of all internal and external stakeholders
- Training internal and external stakeholders on clinical database functionality as needed
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What This Job Offers
Job Type
Full-time
Career Level
Director
