Position: Clinical Data Associate
Report to: Senior Data Management Officer
The Clinical Data Associate will be responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects with minimal supervision. S/he ensures clinical trial data collected meet the highest standards of data integrity.
- Support CRF design, review and validation of clinical database, including supporting management of clinical research activities in this area, if required
- Be responsible for creation of data management plans and other data management documentation as needed; i.e. preparation of monthly, quarterly, yearly reports
- Create ad-hoc data reports as required
- Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines
- Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight
- Be responsible for participating in ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management
- Proactively identify and address issues that may impact the quality of the data, deliverables or timelines
- Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed
- To ensure all clinical data management documentation is stored and archived in a timely and compliant manner
- Work according to ICH guidelines, GCP, GCDMP, and other clinical trial and/or data management applicable standards and maintain the highest levels of professionalism, ethics and compliance at all times
- Performs other related duties as required
- A Bachelor’s degree (or equivalent) with at least 2 years of clinical data management experience in Medical Device or Pharmaceuticals
- Basic to good understanding of medical terminology and medications
- Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc.) is required.
- Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software is required.
- Familiarity with Clinical Data Management System (CDMS) e.g. EDC, EHR
- Detail oriented, strength of multitasking, organizing, and problem solving skills
- Experience with Stata, SPSS is preferred
Please send your full CV, expected salary and recent photo by 15 Aug. 2018
Human Resource Officer. If you want further information related to this position, please contact us via e-mail or phone: 02 252 9958 Only short-list candidates will be notified