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