Serve as a member of the project team with primary responsibility for conducting the clinical data review, query generation / resolution and reconciliation activities to support the Data Management lead with the delivery of clinical data according to client quality and integrity specifications, project timelines and productivity targets. Assist in the development of the project Data Management Plan, including data review guidelines /edit check and eCRF specification. May contribute to setup of the data management systems according to project requirements.
Summary of Responsibilities:
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.
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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.
Qualifications (Minimum Required):
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.
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.
Preferred Qualifications Include:
Knowledge of Fortrea and the overall structure of the organization.
Knowledge of Fortrea standard operating procedures.
Physical Demands/Work Environment:
Office and/or home-based work environment.
May require overtime and weekend work as required.
Should be willing to work in flexible shifts as per business requirement.
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