Clinical Data Associate II - South Africa
- Experience Level
- Experienced (non-manager)
Clinical Data Associate II
Office Based – Bloemfontein
Here at Syneos Health we are currently looking for experienced Clinical Data Associate to be office based in Bloemfontein, South Africa. This is a Sponsor Dedicated opportunity where experience with Inform is strongly desired.
Responsibilities for this role are as follows:
- Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager and/or Biometrics Project Manager as necessary.
- Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).
- Creates and enters test data for User Acceptance Testing (UAT)
- Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices.
- Receives and enters lab normal ranges.
- Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets.
- Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the Data Validation Specification and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries and re-queries where appropriate.
- For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly. Submits copies of the DCFs to sponsors as necessary.
- For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies.
- For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects.
- For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable electronic data capture (EDC) systems.
- Creates electronic storage media per SOPs for EDC studies.
- Participates in internal meetings and internal/external audits as required.
- Files documentation in the Data Management Study File (DMSF).
- Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College).
- Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs.
- Coordinates the work of CDAs assigned to the project.
- Provides training on data management activities and systems.
- Provides project-specific training to other Clinical Data Associates (CDAs).
The ideal candidate will need the following experience / skills to be considered:
- 3+ years experience as a Data Associate
- Experience working with Inform strongly desired
- Experience working in the clinical research industry within a CRO/Pharma/Site
- Experience collaborating with a study team
- Bachelor’s degree preferred, In lieu of Bachelor’s degree, equivalent related education and
- The ability to deal effectively with sponsors and internal customers at all levels
- Excellent communication and interpersonal skills, both written and spoken, with an ability to
- Demonstrated experience in managing multiple priorities in a highly dynamic environment
- Experience working in a matrix-structured environment is preferred
*Preference will be given to those from previously disadvantaged groups that meets the minimum requirements of the position
We have a comprehensive benefits package and offer highly competitive remuneration.
If you have the required experience for this position and are eligible to work in the required location then please apply through our online application.
To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. #LI-LM1