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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, ensuring data integrity and quality while leading a team in a fast-paced environment. Proficient in regulatory compliance, staff training, and effective communication across departments.
Highest-signal resume keywords
Clinical Data ManagementRegulatory ComplianceLeadership SkillsOracle ClinicalData Quality Assurance
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 EntryCRF DesignData CleaningAnalysis DatasetsQuality ChecksProtocol Compliance ReportingDiscrepancy QueriesOutlier EvaluationAdvanced Computer SkillsNeeds Assessment
Soft Skills
Strong Verbal CommunicationStrong Written CommunicationOrganizational SkillsTeam CollaborationMultitasking
Tools & Technologies
Oracle ClinicalQuality Management SystemsEnvironmental Management Systems
Industry Keywords
Pharmaceutical IndustryBio-TechnologyMedical Device IndustryFDA Regulations
Tech Stack
Tools & technologiesOracle
About the role
Key responsibilities & impact- Lead the clinical data review team on-site from the Sylmar, California location
- Manage all data-related activities for clinical studies
- Oversee data entry, CRF design, edit check specifications, clinical database requirements, data cleaning, and analysis datasets
- Ensure clinical database integrity and data quality through protocol compliance reporting, discrepancy queries, outlier evaluation, and quality checks
- Manage custom requests and reporting from clinical databases, including Oracle Clinical
- Provide clinical database outputs to Development, Marketing, and other departments
- Hire, retain, train, mentor, coach, and evaluate data management staff
- Manage subcontractor work output and subordinate performance
- Monitor performance and report statuses to executive management
- Maintain and improve effective, cost-efficient business processes
- Keep current with clinical data management developments, regulatory requirements, and industry trends
- Train staff on changing regulations affecting clinical studies
- Support Quality Management Systems, Environmental Management Systems, and other regulatory requirements
- Maintain a safe, professional, customer-focused work environment and collaborate with employees, customers, contractors, and vendors
Requirements
What you’ll need- Bachelor's degree in a science-related field or an equivalent combination of education and experience
- Minimum 8 years’ progressively more responsible experience in the pharmaceutical, bio-technology or medical device industry
- Ability to apply fundamental concepts and practices to conduct needs assessment, research and develop information for market development purposes
- Advanced computer skills in graphics, word-processing, databases, authoring programs, etc.
- Ability to work in a highly matrixed and geographically diverse business environment
- Strong leadership skills, including ability to set goals and provide positive and constructive feedback respectfully
- Ability to work effectively within a team in a fast-paced changing environment
- Strong verbal and written communication skills
- Ability to multitask, prioritize and meet deadlines
- Strong organizational, planning, and follow-up skills
- Ability to hold others accountable
- Preferred: experience working in a broader enterprise/cross division business unit model
- Compliance with U.S. Food and Drug Administration (FDA) regulations and other regulatory requirements
Benefits
Comp & perks- Career development with an international company
- Free medical coverage eligibility through the Health Investment Plan (HIP) PPO medical plan in the next calendar year
- Excellent retirement savings plan with high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit toward a bachelor’s degree
- Diverse career opportunities
- Health and wellness benefits
- Travel: 10% of the time