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Director, Clinical Data Management
Kailera TherapeuticsPosted 10/19/2026full-timeWaltham • Massachusetts • United StatesLead💰 $196,000 - $240,000 per yearWebsite
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in clinical data management, ensuring data integrity and quality while leading vendor oversight and cross-functional collaboration. Proficient in managing inspection readiness and audit preparation within the pharmaceutical or biotechnology industry.
Highest-signal resume keywords
Clinical Data ManagementVendor ManagementData IntegrityETMF SystemsElectronic Data Capture (EDC)
Tech Stack
Tools & technologiesAbout the role
Key responsibilities & impact- Lead vendor oversight activities across global development programs and align Kailera with CROs on Data Management deliverables
- Provide program-level leadership and oversight of clinical data management activities
- Monitor and report on program and study progress
- Represent Data Management on study teams and foster cross-functional collaboration
- Monitor vendor performance and quality metrics
- Escalate issues and drive resolution strategies
- Identify risks and implement mitigation or corrective action plans
- Ensure Data Management TMF documentation is accurately filed and inspection-ready
- Support study-level inspection readiness and audit preparation
Requirements
What you’ll need- 10+ years of clinical data management experience in the pharmaceutical or biotechnology industry (8+ years with an advanced degree)
- Proven track record providing strategic data management leadership across late-stage development programs, ensuring data integrity, data quality, and inspection readiness
- Expert knowledge of clinical trial data management, including CDASH standards, database lock execution, external data reconciliation (eCOA, central labs, PK), inspection readiness, ICH, GCP, and internal SOPs
- Deep expertise in global CRO oversight, vendor management, and strategic outsourcing models
- Demonstrated experience with eTMF systems and Data Management documentation requirements
- Strong command of electronic data capture (EDC) systems and clinical data warehousing technologies
- Bachelor’s degree in Life Sciences or a related field
- E-Verify employment eligibility for new hires
Benefits
Comp & perks- Comprehensive health coverage
- Flexible time off
- Paid holidays
- Year-end shutdown
- Monthly wellness stipend
- Generous 401(k) match
- Tuition reimbursement
- Commuter benefits
- Disability insurance
- Life insurance
- Annual bonus opportunities
- Equity grants
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial Data ManagementCDASH StandardsDatabase Lock ExecutionExternal Data ReconciliationInspection ReadinessICH GuidelinesGCP ComplianceData Management DocumentationRisk Mitigation StrategiesQuality Metrics Monitoring
Soft Skills
LeadershipCross-Functional CollaborationIssue Resolution
Tools & Technologies
ETMF SystemsElectronic Data Capture (EDC) SystemsClinical Data Warehousing Technologies
Industry Keywords
Pharmaceutical IndustryBiotechnology IndustryCRO OversightStrategic Outsourcing ModelsLife Sciences Degree