Senior Clinical Data Analyst (Bloemfontein OR Irene-Centurion)
Parexel International Corporation
Bloemfontein, Orange Free State, South Africa
3d ago

Job Purpose : -

  • 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.
  • Key Accountabilities : -

  • 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
  • Education :

  • Bachelor’s degree and / or other medical qualifications or relevant industry experience
  • Skills :

  • 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, CRF

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