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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Data Management processes, including data validation, cleaning, and compliance with ICH/GCP Guidelines. Proficient in managing data management documents and leading user acceptance testing while mentoring junior analysts.
Highest-signal resume keywords
Clinical Data ManagementData ValidationICH-GCP GuidelinesClinical Data Management SystemsSAS Programming
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data CleaningDatabase SetupData Management ProcessesMedical TerminologyData Standards (CDISC)Database Configuration SpecificationsData Management Operational ProcessesData ReconciliationUser Acceptance TestingQuery Management
Soft Skills
Problem-SolvingAttention to DetailTime ManagementInterpersonal CommunicationTeam Collaboration
Tools & Technologies
InFormRaveVeevaDataLabsClinBaseMicrosoft Office
Industry Keywords
Clinical ResearchSOPsRegulatory RequirementsTraining ComplianceClinical Study Team
About the role
Key responsibilities & impact- Perform clinical data validation activities on assigned projects with minimal guidance and supervision
- Support data validation activities, Data Management documents and data cleaning matrices
- Perform or lead data validation, cleaning, review and reconciliation activities during study conduct and database lock
- Manage queries, review manual/SAS listings and reconcile external vendor data
- Perform or support setup of Data Management documents and ensure proper documentation
- Lead or perform user acceptance testing on clinical database setups
- Review protocols and EDC entry screens when required
- Provide input on data management timelines and coordinate operational activities during database setup
- Track and review CRFs and support data entry where required
- Ensure compliance with SOPs, ICH/GCP Guidelines and applicable requirements
- Perform or lead functional quality-control activities on databases and patient data
- Maintain training compliance and address identified training needs
- Provide on-the-job training to staff and project teams
- Mentor other clinical data analysts
- Act as a process lead for a specific data validation activity when assigned
Requirements
What you’ll need- Minimum 2 years of experience in the clinical research industry with sound Data Management / Lab experience
- Good knowledge of medical terminology and coding dictionaries (e.g. MedDRA & WHODRUG)
- Good knowledge of Data Management Operational processes and tasks during study start-up, conduct and close-out
- Good knowledge of database set-up activities, including Database Configuration Specifications and setup of Data Validation
- Good understanding of data management processes and data validation flow (e.g. data cleaning, DB lock)
- Good understanding of relevant ICH-GCP Guidelines, local regulatory requirements and Parexel SOPs and study-specific procedures
- Good knowledge of Clinical Data Management Systems (e.g. InForm, Rave, Veeva, DataLabs, ClinBase)
- Good understanding of Clinical Study Team roles within Data Management
- Basic knowledge of SAS (programmed listings)
- Basic knowledge of data standards (CDISC)
- Strong technical aptitude and Microsoft Office computer skills
- Strong problem-solving skills and logical reasoning
- Methodical, analytical and accurate approach to work activities with attention to detail
- Time management and prioritization skills
- Ability to work collaboratively within a team environment
- Ability to coordinate and prioritize tasks for the team in the Primary CDA role
- Good interpersonal, oral and written communication skills
- Learning ability and knowledge-sharing approach
- Flexible attitude toward work assignments and new learning; ability to adjust to changing technical environments
- Evidence of accountability
- Written and oral fluency in English
- Bachelor’s degree and/or other related medical qualification
