Parexel

Senior Clinical Data Analyst

Job description

Job Purpose:
The Senior Clinical Data Analyst (SCDA) shall independently perform all clinical data cleaning activities on assigned FSP projects, commensurate with experience and/or project role. Further responsibilities shall include 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 CRFs. 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 needed

Qualifications

Skills:
  • Personal skills that include:
  • Good interpersonal, oral and written communication skills
  • Excellent learning ability
  • Work with integrity
  • Business / Operational skills that include:
  • Commitment to quality
  • Understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards
  • Sound awareness of relevant regulations, including ICH-GCP, 21CRF11
Knowledge 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 SOPs 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

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