Lead Data Manager - Biotech
- Experience Level
Compass Life Sciences have partnered with an innovative global company who are developing exciting novel products within biology and biotechnology. Our client is looking for an experienced Lead Data Manager to join their team in Southampton.
We are actively recruiting for experienced professionals who are familiar with Data Management Life Cycle and the experience of handling end-to-end activities from data management perspective
Experience in Pre-Clinical, Clinical, Non-Clinical Human Studies or Analytics would be required.
The Lead Clinical Data Manager is responsible for the oversight of all Data Management tasks (including the data management technology set-up of the project) from study start-up to database lock to produce a clean and analysable database.
Provides overall leadership and expertise in all aspect of Data Management via collaborating closely across the external CROs/Vendors/Contractors who independently lead and/or efficiently perform all Data Management activities within an assigned study.
The individual must be able to manage and/or execute multiple projects simultaneously and have a passion for science and evolving data analytics capabilities. The incumbent will actively partner across functional areas and geographies within BAT and with external vendors to ensure R&D project work are met. Additionally, the applicant will be responsible for the oversight of Global DM processes such as data standards development and SDTM review processes, including the management of external vendors who may provide these services.
Demonstrable experience in clinical/data management facilitating data management and data science activities with clinical and/or non-clinical experience. Good solid understanding of ICH and FDA relevant guidelines for data management activities and on CDISC standards with emphasis on CDASH, STDM and ADaM.
Deep understanding of data life cycle for data from product development to registration of regulated products.
Prepares/review relevant SOPs and training/control documents to ensure that the best data management practices are maintained.
Knowledge around SAS programming to coordinate and query datasets using BASE/SAS, including PROC SQL and SAS MACROS.
Proficiency using multiple Electronic Data Capture Systems, such as: Oracle Clinical, Medrio, Inform, Medidata Rave, etc.
Seizes opportunities to improve the Data compilation and management through its life cycle.
Provides training and mentors other team members and wider R&D scientific community in the best data management practices and data standards.
Bachelor's Degree Required and previous working experience of vendor management is essential.
Our client is offering a generous package, competitive salary, and an opportunity to progress within a global organisation. Contact Gareth Hughes-Jones FREC
Head of Data and Bioinformatics
023 9231 6034
Alternatively, recommend someone. Compass Associates Ltd, trading as Compass Life Sciences, are acting as a Recruitment Consultancy for this permanent vacancy; we offer £250 worth of Amazon for each successful recommendation.