Senior Clinical Data Analyst
An opportunity has arisen in London for a Senior Clinical Data Analyst to join a global biotech and make massive contributions to science.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.
- 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.
Skills and Requirements
- Bachelor's degree as a minimum
- 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).
- 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.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.