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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, including oversight of data collection, validation, and compliance with CDISC standards. Proven ability to lead cross-functional teams and manage the clinical trial lifecycle effectively.
Highest-signal resume keywords
Clinical Data ManagementEDC SystemsCDISC StandardsProject ManagementData Reconciliation
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 Trial OperationsData Flow ValidationData Cleaning ValidationQuery ManagementData VisualizationRisk ManagementUAT DocumentationDatabase Lock DocumentationMetadata Management
Soft Skills
CommunicationStakeholder ManagementCollaborationMentoringFacilitation
Tools & Technologies
ECOADigital Health TechnologiesLaboratory Data SystemsImaging SystemsVendor Portals
Industry Keywords
Clinical Development LifecycleICH-GCP21 CFR Part 11SOPsPrivacy Requirements
About the role
Key responsibilities & impact- Lead end-to-end clinical data management activities from study start-up through database lock and archival
- Provide strategic and operational oversight across the trial lifecycle
- Serve as the primary data management contact for cross-functional teams
- Oversee clinical data collection design, validation, reconciliation, remediation, and query strategy
- Oversee review and reconciliation of data from EDC/DDC, eCOA, digital health technologies, laboratories, imaging, biomarkers, and vendor portals
- Own risk-based data quality oversight, root-cause analysis, mitigation plans, and strategic escalations
- Oversee data acquisition, integration, data flow validation, and data cleaning validation specifications
- Integrate specimen, specialty, and laboratory data strategies into the trial data approach
- Oversee development, review, approval, execution, and maintenance of DMPs, DVPs, eCRFs, specifications, UAT documentation, coding plans, database lock documentation, and archival readiness documentation
- Own UAT and change control activities across systems, tools, and data flows
- Ensure implementation and traceability of CDISC data standards and controlled terminology
- Ensure compliance with privacy policies, 21 CFR Part 11, regulations, and inspection-readiness requirements
- Represent data management on Clinical Trial Teams and governance forums
- Provide oversight, mentoring, and training to Clinical Data Managers and External Data Specialists
- Facilitate cross-functional meetings, documented decisions, and action plans
- Oversee data management for acquisition, partnership, and non-standard trials
- Contribute project management, leadership, and expertise to process, standards, platform, and tool initiatives
Requirements
What you’ll need- Non-Degree or associate's degree with minimum 10 years of directly relevant experience in data management, clinical trial operations, or related field
- Bachelor's Degree with minimum 8 years of experience in data management, clinical trial operations, or related field
- Advanced Degree (Masters or Doctorate) with minimum 4 years of experience in data management, clinical trial operations, or related field
- Deep understanding of the clinical development lifecycle, data flow, and cross-functional dependencies
- Strong command of clinical data management platforms, EDC systems, eCOA, query management, data reconciliation/integration, and data visualization/dashboarding tools
- Extensive experience designing, validating, and maintaining integrated data management deliverables and validation components
- Demonstrated understanding of CDISC standards, including CDASH, SDTM, Define-XML, metadata management, and controlled terminologies
- Working knowledge of SOPs, ICH-GCP, 21 CFR Part 11, Annex 11, and privacy requirements
- Solid foundation in clinical practice and medical terminology
- Project management, planning, execution, and risk management skills
- Fluent in English
- Exceptional communication, influencing, stakeholder management, collaboration, facilitation, mentoring, and knowledge-sharing skills
- No visa sponsorship
- No relocation
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- 10% travel