Senior Clinical Data Analyst (FSP)

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 proficiencyand autonomyLead/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 studiesTrack 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 testingMentor project team membersBe a subject matter expert when neededQualificationsSkills:Personal skills that include:Good interpersonal, oral and written communication skillsExcellent learning abilityWork with integrityBusiness / Operational skills that include:Commitment to qualityUnderstanding of Global Data Operations tasks, specifically within Data Management and Database Programming and relevant data standardsSound awareness of relevant regulations, including ICH-GCP, 21CRF11Knowledge and Experience:Experience in clinical researchGood interpersonal, verbal and written communication skillsKnowledge of medical terminology and awareness of coding dictionaries (e.g.MedDRA & WHODRUG)Ability to work in team environmentGood analytical skills and attention to detailEffective time management to meet daily metrics or team objectives, completion of assigned tasks in a timely mannerRobust knowledge of ICH-GCP Guidelines, local regulatory requirements and PAREXEL SOPs and study specific proceduresGood 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 ValidationBasic knowledge of SASEducation:Bachelor’s degree and / or other medical qualifications or relevant industry experience