Job Description
Your key responsibilities:
Your responsibilities include, but not limited to
- Basic knowledge in OC, LSH, SDTM and also carries good understanding of data standards who can lead/assist the development, maintenance and implementation of standards.
- Work with the Governance/approval Board and other DB operations associates and/or members of vendor metadata team.
- Perform comprehensive DB Set up Plan and execute full go live of DB set up. Overall, will ensure quality DB set up within Medidata RAVE EDC system.
- Perform impact analysis for proposed modifications to existing domains, permitted choices for discussion with Governance as necessary. Support development and testing of all new Medical Clinical Solutions team Library objects needed for clinical studies.
- Document, support development, review and maintain global library copy groups of DCMs, DCIs, Procedures, Views, maintain Form Layout Templates, Extract Macros and Key Templates DCI books for reuse of standard pages for individual trials.
- Contribute to the review of global SOPs. Ensure alignment between OC Global Library Objects and Metadata Repository.
- Understanding and Leading the Life Science Data Hub (LSH) programming activities for all new Medical Clinical Solutions team projects implemented on Novartis Clinical Data Standards platform.
- For studies in scope initiate data extraction, pre-conformance, conformance and post-conformance of clinical data into NCDS standards based on study conformance plan and ensure data refresh as per the schedule. Review Data Transfer Specifications (DTS), grant access to vendor/CRO for loading data into IWC.
Minimum requirements
What you ll bring to the role
- University or college degree in life science, pharmacy, nursing statistics, biostatistics or equivalent relevant degree.
- Basic knowledge/understanding and experience of applications like Oracle Clinical and standard reporting systems like CDISC/SDTM.
- 7 + years experience in drug development, with at least 5 years in Data Management activities.
- Experience in managing outsourced studies or working for a CRO is desirable.
- Thorough understanding of physiology, drug development process, clinical trial methodology, GCP, medical terminology, and coding.
- Good organizational and project management skills. Good negotiation skills. Ability to mentor, coach within Data Management and cross functionally.
- Ability to work independently, under pressure, demonstrating initiative and flexibility.
- Good interpersonal and communication skills and ability to operate effectively in an international environment.