Leeds Studio 3, Photon House Percy Street Leeds LS12 1EL
Clinical Standards Consultant 2022-08-22 We are looking for a Clinical Standards consultant to help develop new standard processes and oversee the re-build of high volumes of trials globally. Vine Resources 2022-09-22

Clinical Standards Consultant

Remote UK or Europe / contract / Negotiable

David Lawrence

0 DAY

Negotiable

GBP
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Clinical Standards Consultant

We are looking for a Clinical Standards consultant to help develop new standard processes and oversee the re-build of high volumes of trials globally.

 

Role

*Assist in defining companywide standards to be used in all trials, thereby ensuring the accuracy and integrity of all trial and project databases.

*You'll be working closely with the Project Data Managers (PDM) to implement project standards and a harmonized approach to all database issues within all trials, projects and Therapeutic areas (TA).

*You will help 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.

*Help with the definition and be able to approve trial database build specifications for implementation by database designers.

*Periodically review the approved and used data standards, and continuously improve the harmonization in therapeutic areas

*Review industry guidance and evaluate the impact on company data structures. Suggest implementation strategy and migration topics.

 

Experience

*You'll be experienced with over 10 years within Clinical Data Standards with either a Pharma/Biotech or CRO company

*You'll be experienced with CDISC industry standards, including CDASH, SDTM, and NCI-controlled terminology.*Data processing skills, technical expertise and/or programming skills (preferably SAS).

*Basic knowledge in database set-up; Medidata Rave preferred. *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 interpersonal communication skills and able to work with many stakeholders globally

 

 

This is a fully remote long-term contract