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 and, with Oracle Life Sciences immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.
Career Level - IC3
This individual will be involved in managing data-related tasks for designated studies and ensuring their completion on time and within budget. This individual must have an experience with SAS programming and strong SDTM standard knowledge. This individual will be involved in the creation and review of SDTM deliverable (annotated CRF, SDTM specifications, SDTM . You will communicate with the study team members and the sponsor regarding CDISC requirements and issues.
Also, this individual, guides, coaches, and develops junior members of the team and acts as a role model in this context.
Expectations:
Effectively plan and execute multiple Data Management projects simultaneously. Create and maintain relevant Data Management documentation and guidelines, such as Data Management Plan (DMP), Data Validation Plan (DVP), eCRF Completion Guidelines with the minimum of supervision Program and validate of sponsor specific SAS Datasets as of SDTM structure Create and validate SDTM specifications and SDTM annotated CRF Generate the SAS annotations and SAS specifications based on the client and CDISC standard Support the programming and validation of the EDC databases Program and validate internal and client specific external status reports and listings Create and maintain relevant Programming documentation Develop diverse programming specifications Effectively plan the Programming tasks to support the Data Management on multiple projects simultaneously Resolve any issues and solve problems throughout project lifecycle Attend Sponsor requested meetings as required
Desired experience:
University degree in Medical Documentation/Life Science/Biological Science/Informatics or a related discipline in the science/healthcare field or equivalent education At least 4 years of experience in (Clinical) Data Management within a pharmaceutical company or CRO or an equivalent combination of education and experience to successfully perform the key responsibilities of the job Programming skills in SAS, SQL and Access databases Knowledge and experience in CDISC SDTM mandatory Performance-oriented, well-structured and efficient work methods Ability to work both independently and efficiently within an interdisciplinary team Excellent planning, organisation, and communication skills Proficient computer skills in MS Office
