Job Duties Required:
· Ensures that all allocated projects are carried out in strict accordance with the relevant protocols, global harmonized SOPs, and the specified standards of GCPs.
· Demonstrates capability to read and follow study timelines for on-time deliverables.
· Potential to assist with inputs on study design or capable to make suggestions to study timelines when warranted.
· Assist with review of clinical trial data in accordance with Data Management Plans and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data.
· Run and execute additional programs (special listings, reconciliation discrepancy listings, etc.) used to support the review of clinical trial data.
· Generate, resolve and track queries to address problematic data identified during aggregate data review activities.
· Interacts with other project team members to support the set-up, maintenance, and closure of the Data Management aspects of the project and attend meetings as required.
· Generate and QCs data listings for internal data review.
· May assist or create dummy data to test edit checks and to test database screen design and functionality.
· Assist or create dummy data to test SAS reports and data listing.
· Demonstrates the ability to review Edit Check Specifications and Database specifications.
· Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required.
· Runs study status reports in preparation for Sponsor meetings and to deliver on specific Sponsor request.
· Assist with the completion of Database Lock and Unlock activities.
· Supports the training of new staff on project specific Data Management processes.
· Performs any other duties as assigned.
Experience: Minimum Required:
· 3 to 5 years of relevant work experience with increasing responsibility in data management with knowledge of one (1) or more therapeutic areas.
· Demonstrated time management skill and ability to adhere to project productivity metrics and timelines.
· Knowledge of medical terminology is preferred.
· Knowledge of effective clinical data management practices.
· Knowledge of science or a scientific background is preferred.
· Good oral and written communication skills.
· Demonstrate time management skill and ability to adhere to project productivity metrics and timelines.
· Demonstrate ability to work in a team environment and collaborate with peers.
· Demonstrate good organizational ability, communication, and interpersonal skills.
· Demonstrate team working skills and good collaborator skills.
· Demonstrate a constructive problem-solving attitude while deadline focused with time demands, incomplete information or unexpected events.
· University / college degree (life sciences, health sciences, information technology or related subjects) or a certification in allied health professions from an appropriate accredited institution.
· Fluent in English, both written and verbal.
Apply : https://careers.labcorp.com/global/en/job/2276568/Clinical-Data-Specialist
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