Social network you want to login/join with:
Senior Clinical Data Manager/Programmer, United Kingdom
Client: Oracle
Location: United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: 4df8264b1300
Job Views: 7
Posted: 26.04.2025
Expiry Date: 10.06.2025
Job Description:
Oracle Life Sciences is a leader in cloud technology, pharmaceutical research, and consulting, trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance, throughout the therapeutic development lifecycle, including pre- and post-drug launch activities. With more than 20 years’ experience, Oracle Life Sciences is committed to supporting clinical development and leveraging real-world evidence to deliver innovation and accelerate advancements – empowering the Life Sciences industry to help improve patient outcomes.
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences. Oracle Life Sciences is immersed in these areas, making it an excellent opportunity to join us and make a difference to our clients and patients.
This role involves managing data-related tasks for designated studies, ensuring their completion on time and within budget. The candidate must have experience with SAS programming and strong SDTM standard knowledge. Responsibilities include creating and reviewing SDTM deliverables (annotated CRF, SDTM specifications, SDTM datasets), and communicating with study team members and sponsors regarding CDISC requirements and issues.
The individual will also guide, coach, and develop junior team members and act as a role model.
Key Responsibilities:
* Plan and execute multiple Data Management projects simultaneously.
* Create and maintain Data Management documentation such as DMP, DVP, and eCRF Completion Guidelines.
* Program and validate sponsor-specific SAS Datasets according to SDTM structure.
* Create and validate SDTM specifications and annotated CRFs.
* Generate SAS annotations and specifications based on client and CDISC standards.
* Support programming and validation of EDC databases.
* Program and validate internal and external status reports and listings.
* Create and maintain programming documentation.
* Develop programming specifications.
* Plan programming tasks to support Data Management across multiple projects.
* Resolve issues and problems throughout the project lifecycle.
* Attend sponsor meetings as required.
Desired Experience:
* University degree in Medical Documentation, Life Sciences, Biological Sciences, Informatics, or related discipline.
* At least 4 years of experience in Clinical Data Management within a pharmaceutical company or CRO.
* Programming skills in SAS, SQL, and Access databases.
* Knowledge and experience in CDISC SDTM.
* Performance-oriented with well-structured and efficient work methods.
* Ability to work independently and within interdisciplinary teams.
* Excellent planning, organizational, and communication skills.
#J-18808-Ljbffr