The Senior Clinical Data Analyst shall independently perform all clinical data cleaning activities on assigned 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 Senior CDA may act as a Data Management Lead where required.
Key responsibilities : Lead / Responsible for data cleaning and data review activities e.g. query management. 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.
QualificationsIdeal candidate will possess : Proven ability to lead and collaborate with global and cross-functional teams - ability to coordinate & prioritize tasks for the DM operational and programming teams (when) in the Primary CDA role.
Ability to independently interact with Sponsor liaison to discuss data issues / project data validation requirements, as needed.
Experience and understanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standards.
Experience in clinical research (Pharma / CRO). Bachelor’s degree as a minimum. Excellent interpersonal, verbal and written communication skills.
Knowledge of medical terminology and awareness of coding dictionaries (e.g. MedDRA & WHODRUG). Robust knowledge of ICH-GCP Guidelines.
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. Fluent English. 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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