Senior Clinical Data Analyst - based in UK, Romania, Poland, Hungary
Romania, Remote ID de la oferta R0000025392 Categoría Data Managementsobre este trabajo
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:
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 as a minimum.
Fluent English.
Proven experience in clinical research (CRO/Pharma).
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.
Excellent 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.
Basic knowledge of SAS.
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