Job Overview:
Serve as a member of the project team with primary responsibility for coordinating 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 /diagnostics specification and setup of the data management systems according to project requirements. Serve as back-up to Clinical Data Manager, with oversight of data management activities for the delivery of clinical data according to client quality and integrity specifications, project timelines and budgets.
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.
- Perform all data management tasks as appropriate to include, but not to be limited to data review and query management to ensure that quality standards (both internal and client) are achieved within stipulated timelines. Assist with reviewing clinical trial data in accordance with Data Management Plans, Edit Check Specifications and/or Data Review Guidelines and raise queries to resolve erroneous, missing, incomplete data.
- Generate, resolve and track queries to address problematic data identified during aggregate data review activities.
- Run and execute additional programs, special listings, reconciliation discrepancy listings etc.) used to support the review of clinical trial data.
- Interact 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.
- Assist with review of data listings for internal data review.
- 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.
- Modify standard templates to create study specific Data Management Plans, or eCRF completion guidelines.
- Support team members by creating forms/memos as required.
- Posting of Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required.
- Generate study status reports.
- Perform database extracts.
- Assist in the creation of slides for Investigator Meeting and Site Initiation Visit or similar meetings.
- Assist with the completion of Database Lock activities.
- Support 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):
- 2 to 4 years of applicable experience in clinical research (Data management preferred).
- Additional experience may be substituted for education requirements.
- Knowledge of medical terminology.
- Demonstrate time management skills 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 and good collaboration skills.
- Knowledge of drug development process.
- Knowledge of effective clinical data management practices.
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.
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