Senior Clinical Data Analyst (FSP), South Africa at PAREXEL

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.