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Senior Clinical Data Manager
Clinical Outcomes Solutions. Independently lead data management study activities, CRO oversight, and deliverable timelines .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Data Management, including leading data management activities, managing EDC systems like RAVE, and ensuring compliance with GXP requirements. Proven ability to collaborate with stakeholders and manage deliverables while maintaining data quality and readiness for inspections.
Highest-signal resume keywords
Lead Clinical Data ManagerRAVE EDC SystemsClinical Data ManagementData Management Best PracticesGXP Compliance
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 ManagementClinical Data ManagementEDC SystemsVariance AnalysisForecastingMetrics PreparationProcess MappingSOP MaintenanceSubmission ReadinessRisk Mitigation
Soft Skills
CollaborationStakeholder ManagementProblem SolvingLeadership
Tools & Technologies
RAVEElluminate
Industry Keywords
CRO OversightClinical OperationsStatistical ProgrammingTherapeutic Area UnitsSCDMCDISCDIA
About the role
Key responsibilities & impact- Independently lead data management study activities, CRO oversight, and deliverable timelines
- Build EDC systems utilizing RAVE
- Represent data management on the Clinical Sub-team and align CRO and client expectations for data deliverables
- Collaborate with stakeholders to meet milestones and deliverables with high quality
- Partner with stakeholders and CRO partners to mitigate and resolve risks
- Support functional governance with strategic suppliers and resolve escalated issues
- Prepare the function for submission readiness and represent it in inspections or audits
- Maintain archival and inspection readiness of Data Management Trial Master File documents
- Coordinate data management deliverables and milestones with Therapeutic Area Units, Clinical Operations, Statistical Programming, and Statistics
- Plan and manage external Data Management budgets and timelines, including variance analysis and forecasting
- Act as a process expert for operational and oversight models
- Maintain SOPs, process maps, templates, and timelines
- Prepare metrics supporting functional KPIs
- Represent the function in external professional initiatives and organizations such as SCDM, CDISC, and DIA
- Contribute strategic direction to continuous improvement initiatives
- Ensure compliance with learning curricula, corporate, and GXP requirements
- Work cross-functionally to ensure database data quality, on-time delivery, and quality of data management deliverables
- Perform other duties as assigned
Requirements
What you’ll need- Proven recent experience as a Lead Clinical Data Manager with substantial RAVE experience
- Bachelor's Degree in a science, health related, or IT field
- Minimum 6 years' experience in Clinical Data Management at the CRO or pharma level
- 2 years as a CDM lead
- Experience with all phases of development
- Strong knowledge of data management best practices and technologies
- Experience with Elluminate is preferred, not required
Benefits
Comp & perks- Commitment to developing staff and supporting significant professional growth