Clinical Data Specialist Opening @ PRA
Overview
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.
Responsibilities
Provide professional DM input on Clinical Trial Team(s)
Input to and review of clinical trial database design including User Acceptance Testing (UAT).
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.
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.
Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design with supervision.
Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper.
Support and assist data management staff for allocated trials.
Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock.
Perform training on data management software and practices or trial specific topics as required.
May participate in preparation of training materials for data management activities and processes.
KPIs:
Meet established KPIs. Timely and high quality completion of Data Management deliverables according to established objectives, including: CRF Design, UAT of eCRF. Fast and high quality Database Lock, EDC User Training.
Qualifications
Education (minimum/desirable):
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.
Languages:
Fluent English (oral and written).
Experience/Professional requirement:
Minimum of 2 years experience in drug development and at least 1 year experience in Data Management
University Science Degree in life sciences, pharmacy, nursing or equivalent relevant experience.
Excellent written and oral English skills
Understanding of clinical trial methodology, GCP and medical terminology
Good computer skills
Good organizational and project management skills.
Good communication and interpersonal skills
Basic presentation and problem solving skills
Ability to work well in a team with or without supervision
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