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.

• 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.

Learn more about our EEO & Accommodations request here.