Summary: Work with Study Data Manager and study team members to develop clinical database using Medidata's Rave EDC system to meet First Patient First Visit timeline and to maintain and update the database as needed during the study conduct. Ensure implementation of standards in clinical database during the startup and the study conduct. Support EDC data transfer, data snapshot, database lock and post data lock subject data archival processes. Support Study Data Manager with database development and maintenance related documentation at required intervals. Provide technical services using clinical data programming in SQL, utilizing clinical data repositories, and developing reports and/or visualizations using BI tools.
* Work with Clinical Study Data Managers to implement comprehensive eCRF system in Rave Architect using the Global CRF Library, prior studies, and new unique CRFs. Design and test unique CRFs as needed per study team requirements. * Define data validation requirements including edit checks, dynamics, derivations, and custom functions. Program data validations in Rave Architect, including edit checks, dynamics derivations, and custom functions prior to completion of eCRF build. For complex and new custom functions, work with Medidata to oversee programming and testing of custom functions. * Facilitate UAT process by publishing UAT environment, inviting UAT participants via iMedidata, and resolving reported issues for the duration of UAT until system is deemed ready for go-live. * Set up Clinical Views per company standards. * Contribute to the creation of CDASH-compliant eCRF. Maintain and contribute to company Standard Global Library. * When applicable, work with vendor on EDC and 3rd party system integration. * Ensure go-live of Rave EDC system in a timely manner prior to first subject first visit with full testing completed. Ensure proper documentation and approval of specifications and testing. * Maintain eCRF system for the duration of the study. Perform change-control by defining any eCRF Change Requirements, including CRF updates due to protocol amendments, clarifications, and post-production issues identified by users. Document change-control requirements, version updates, UAT, and migration testing. * Assist with the creation of standard and custom reports in EDC using relevant reporting tools. * Act as a primary contact to data management team to provide all necessary technical support and to ensure quality programming and adherence to company standards. * Routinely interface with cross-functional team members. * Act as liaison with CROs/vendors as needed, to establish and ensure company standards (for example, data transfer specifications) are implemented and maintained in all studies. * Support/develop and maintain SOPs related to EDC build process. * Participate and lead Clinical Database Development team meetings when needed.
Knowledge, skills, and abilities required:
* Has in-depth and breadth of clinical expertise in database design, data standards, and data output programming using multiple technology solutions * Experience with clinical trial data technologies, including: programming in SQL, utilizing data repositories (elluminate® experience preferred), and developing reports / visualizations using BI tools (Qlik a plus) * Has broad knowledge of Clinical Data Management and other Clinical Development functions * Strong EDC skills in various EDC systems, e.g., Medidata Rave * Demonstrates ability to anticipate internal business challenges and successfully drives towards the best solution for the organization * Recognized as an EDC, external data handling, and data visualization expert, and is an escalation pathway throughout Clinical Development organization * Must be able to work in a highly matrixed fast-paced environment with changing priorities and deadlines * Proven track record of designing, leading and executing initiatives such as EDC global library design or standard data visualization implementation, that have meaningful impact on critical goals * Highly organized and detail oriented * Able to manage time effectively and prioritize * GCP and Therapeutic Area knowledge * Demonstrated experience in writing professional correspondence and clinical study documentation * Strong understanding of clinical trial data * Strong communication skills
* Bachelor's degree, preferably in health science or related field * Direct experience in clinical data management environments throughout the study lifecycle (e.g., design, build, maintain, migrate, lock) * Rave Certified Study Builder and Custom Function Programming a plus
About Bluebird Bio
Bluebird Bio offers products based on the transformative potential of gene therapy for patients with genetic and orphan diseases.