Senior Clinical Data Analyst (Bloemfontein or Centurion, South Africa)
Parexel International Corporation
South Africa - Any Region - Home Based
* The Senior Clinical Data Analyst (SCDA) shall independently perform all clinical data cleaning activities on assigned projects, commensurate with experience and/or project role.
* Further responsibilities shall include acting as Study Team Lead, support on data processing activities and study level documents e.g. Protocol Deviation Specification, Data Validation specification, etc.
* The SCDA may act as a Data Management Lead where required.
* Assume the ability to meet the requirements of a CDA III roIe with a high degree of proficiency and autonomy
* Lead/Responsible for data cleaning and data review activities e.g. query management.
* Management of project timelines (including creation, review and tracking of plans)
* Review of protocols and EDC Screens if required.
* Support data processing activities from database setup to database lock, e.g. SAE reconciliation.
* Perform user acceptance testing on study database setups.
* Perform medical coding on small studies
* Track and review CRF's. Support data entry where required.
* Perform and or support the setup of DM documents and ensure proper documentation e.g. CRF Completion Guidelines (CCG)
* Perform/lead functional QC activities and testing
* Mentor project team members
* Be a subject matter expert when neededQualificationsKnowledge and Experience:
* Experience in clinical research
* Good interpersonal, verbal and written communication skills
* Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG)
* Ability to work in team environment
* Good analytical skills and attention to detail
* Effective time management to meet daily metrics or team objectives, completion of assigned tasks in a timely manner
* Robust knowledge of ICH-GCP Guidelines, local regulatory requirements and Parexel SOP's and study specific procedures
* Good knowledge of EDC systems (e.g. DataLabs, Rave.)
* Good knowledge of electronic source data capture systems (e.g. ClinBase)
* Good knowledge of all DB set- up activities including but not limited to Database Configuration Specifications, Data Validation
* Basic knowledge of SAS
* Bachelor’s degree and / or other medical qualifications or relevant industry experience
* Personal skills that include:
o Good interpersonal, oral and written communication skills
o Excellent learning ability
o Work with integrity
* Business / Operational skills that include:
o Commitment to quality
o Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards
o Sound awareness of relevant regulations, including ICH-GCP, 21CRF11