ProClinical has a brilliant opportunity for a Clinical Data Acquisition to be based in Belgium on a permanent basis. This job will be with one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors.
- Ensure eCRF is built according to the latest standards and best practices, including edit checks and applicable integrations (IWRS, CTMS, etc.); translate protocol requirements into optimal data capture approaches; oversee eCRF build and updates by CRO or vendor to confirm quality.
- Provide specifications for data models to be used for quality review and for final data model (SDTM or other); design mapping algorithms for nonstandard conversions.
- Ensure quality review of datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive design, etc.) and compliant for Database lock.
- Ensure non-eCRF technologies for data capture (e.g., ePRO, safety reporting, coding, IWRS) are deployed as per requirements, including integrations with other systems, platforms or reporting environments with timelines for consumable data outlined.
- Oversee development of data transfer agreements with ancillary data vendors ensuring use of standards, fit-for-purpose data models and transfer intervals.
- Develop and maintain working knowledge of programming languages utilized in data management (SAS, SQL, etc.).
- Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory requirements.
- Responsible for acquiring and maintaining working knowledge in the various and future evolving data collection tools applied in the clinical trial space such as Medidata Rave, LSAF, Pinnacle 21, and in CDISC standards such as SDTM, CDASH, Controlled terminology and define.xml.
- Ensure standards are used at the trial level.
Skills and Requirements:
- A Bachelor's degree or professional experience equivalent (0-3 years) is required.
- A minimum of 0-3 years of experience in data management (data review, database management, standards development, statistical or data management programming, CRF build, etc.) is required.
- Ability to work in a team setting is required.
- Understanding of eDC systems, e.g. Medidata platform of tools, Clinbase, etc. is preferred
- Basic programming skills or analytical programming language (SAS, SQL, C++) is preferred
- Understanding of analytical reporting systems, e.g. Spotfire or BOXI is preferred
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sam Walker on +44 203 8569 336 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies