Senior Clinical Data Analyst

Job description

What you will do:

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.


Ideal candidate will possess:
  • Bachelor’s degree and / or other medical qualifications.
  • 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.
  • Experience in clinical research.
  • Good interpersonal, verbal and written communication skills.
  • Knowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG).
  • 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.
  • 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.
  • Basic knowledge of SAS.


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