Clinical Data Coordinator - Bloemfontein, South Africa
Office-based Who We Are
Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of "Bringing Clinical Trials to Life," we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.Position Overview
The Clinical Data Coordinator supports the Clinical Data Manager in the delivery of Data Management contracted services on assigned projects. This includes responsibility for tasks and processes associated with database build, data review and closure of the database. Specific tasks would include:
- Reads and follows the Data Management Plan (DMP) for ongoing projects.
- Assists in the development of Clinical Data Management Database Systems including QC or testing activities required for database finalization.
- Performs testing on custom reports and listings.
- Assists with the development of supporting Data Management documentation as required, including but not limited to: CRF Completion Guidelines, Test Subject Cases and Data Entry Guidelines.
- May perform data entry and/or verification tasks as necessary for assigned projects.
- Conducts Data Management tasks for data review, including the production of reports, listing, or other outputs required, authoring/ issuing queries, data reconciliation and query updates.
- Assists the Clinical Data Manager with data review metrics and reporting
- Conducts database maintenance activities, including permissions activities, end-user training, and maintenance activities of training records.
- May act as back up support to the Clinical Data Manager for sponsor facing communications as required.
- Exports data from the clinical database to provide either internally or externally.
- Conducts all activities and files documentation in accordance with SOP requirements and TMF filing guidelines.
- Performs final Quality Control check of profiled clinical data against paper CRFs for paper studies.
- Bachelor's degree in a related field of study or equivalent combination of education and work experience.
- 2 years experience in clinical research preferred.
- Medical terminology exposure preferred.
- Knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
- Transferable skills in a related industry role is an asset.
- Proficiency in Microsoft Word, Excel, and Outlook
- Effective verbal and writing skills; English + local language, if relevant.
If you're passionate about bringing clinical trials to life, we encourage you to apply today!
Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, colour, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.