Clinical Data Standards Advisor

Remote role * work from home in UK/Europe or USA

My client is a leader in the Pharma industry setting the standards in clinical development globally. As part of their continued investment in ensuring he highest standards, we require a Standards governance advisor to oversee the re-build of a high volume of trials globally.


Role

*Define and release company metadata structures within the MDR system.
*Define and maintain EDC global library elements, including eCRFs, fields, data dictionaries, and procedure specifications.
*Define and/or approve trial database build specifications for implementation by database designers.
*Evaluate, release, and maintain new standard elements.
*Periodically review the approved and used data standards, and continuously improve the harmonization across all therapeutic areas within BI worldwide.
*Review industry guidance's and evaluate impact on BI data structures. Suggest implementation strategy and migration topics.
*Lead or participate in working groups and committees related to eCRF structures and electronic data capture.
*Develop and implement mapping from different data structures to others (e.g. Project Databases (PDBs), EDC raw data extracts to SDTM, PDB to ADaM etc.)
*Train BDS organisation worldwide in CDISC standards use.
*Guide PDMs in data standards and mapping rules set up.
*Set up migration plans and mapping strategy for legacy projects.



Experience

You will be experienced with global clinical standards providing guidance, governance and support
You will have an in-depth comprehension of CDISC standard
Experience with Medidata Rave will be a huge asset but not essential.
Good organizational skills, problem-solving abilities, time management skills and initiative.
Flexibility and ability to work on several assignments simultaneously. Must be able to work independently as well as part of a team.
Good written and oral communications skills in the English language.
Excellent interpersonal communication skills.
Must be precise, detail oriented, and able to detect subtle inconsistencies in the data.
Continuing education in clinical trial designs and monitoring procedures, GCP and ICH regulations and clinical data processing and reporting.



If you have the skills and experience and passion for this role, please get in touch for a confidential conversation. Initially this will be a 12-month contract working remotely from home.