Opportunity to work as Clinical Data Specialist in PRA HEALTH SCIENCES
A leading global CRO, PRA is transforming clinical trials through our people, innovation and transparency. We serve clients across all phases of pharmaceutical and biotech drug development by combining therapeutic and operational expertise with local knowledge
PRA’s commitment to excellent in research begins with our people. Our workforce has grown by over 25% since 2010 and now comprises over 4,700 employees spanning more than 13 time zones and speaking more than 15 languages.
It is our philosophy that the way in which we grow our business is to focus on our employees and as such, we recognize that successful careers are found within organisations that provide the support that employees need at work, as well as the benefits they require outside the office.
Post: Clinical Data Specialist
Provide timely and professional ongoing management of clinical trial data by identifying and resolving errors and inconsistencies in eCRF data to ensure consistently high standard database(s) with respect to cost, quality and timelines.
1. Provide professional DM input on Clinical Trial Team(s).
2. Input to and review of clinical trial database design including User Acceptance Testing (UAT).
3. Provide input for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes taking an active part in the meeting, providing input in writing the study specific validation checks and necessary reports to ensure high quality and consistent data.
4. Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks.
5. Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design with supervision.
6. Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper.
7. Support and assist data management staff for allocated trials.
8. Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock.
9. Perform training on data management software and practices or trial specific topics as required.
10. May participate in preparation of training materials for data management activities and processes.
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
Languages: Fluent English (oral and written)
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