Clinical Data Specialist

Job description

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 .