Director, Clinical Data Management
Sonoma County, CAFull-timePosted Apr 3, 2026
Behavioral Health Market Context
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Job Description
emote-only arrangements will not be considered.
What You'll Own
• End-to-end CDM accountability across Phase I–III studies, from database design through database lock
• Build, manage, and develop a high-performing CDM team
• Drive CRF design, data validation specifications, edit check development, and data management planning
• Oversee CRO and CDM vendor performance — scope, timelines, quality, and escalation
• Lead CDISC/CDASH standards implementation and ensure consistency across the portfolio
• Serve as the CDM functional lead on cross-functional study teams alongside Biostatistics, Clinical Operations, and Regulatory
• Ensure inspection readiness across all active studies; represent CDM in regulatory audits as needed
• Partner with IT and systems teams on EDC platform management and optimization
What We're Looking For
• 10+ years of clinical data management experience in pharma, biotech, or CRO settings
• 4+ years leading or managing CDM teams
• Proven track record across multiple concurrent global trials, Phase I through III
• Strong EDC platform experience (Medidata Rave or equivalent)
• CDISC standards expertise — CDASH required, SDTM familiarity expected
• Experience with multi-CRO oversight and risk-based monitoring models
• Regulatory inspection experience (FDA, EMA, or equivalent) preferred
• Direct communicator with the credibility to engage senior cross-functional stakeholders
Education
Bachelor's degree in a life sciences or related field required. Advanced degree a plus. CCDM certification viewed favorably.
Location & Schedule
Hybrid schedule with weekly on-site presence required. Candidates must reside within commuting distance or be open to relocation.
What You'll Own
• End-to-end CDM accountability across Phase I–III studies, from database design through database lock
• Build, manage, and develop a high-performing CDM team
• Drive CRF design, data validation specifications, edit check development, and data management planning
• Oversee CRO and CDM vendor performance — scope, timelines, quality, and escalation
• Lead CDISC/CDASH standards implementation and ensure consistency across the portfolio
• Serve as the CDM functional lead on cross-functional study teams alongside Biostatistics, Clinical Operations, and Regulatory
• Ensure inspection readiness across all active studies; represent CDM in regulatory audits as needed
• Partner with IT and systems teams on EDC platform management and optimization
What We're Looking For
• 10+ years of clinical data management experience in pharma, biotech, or CRO settings
• 4+ years leading or managing CDM teams
• Proven track record across multiple concurrent global trials, Phase I through III
• Strong EDC platform experience (Medidata Rave or equivalent)
• CDISC standards expertise — CDASH required, SDTM familiarity expected
• Experience with multi-CRO oversight and risk-based monitoring models
• Regulatory inspection experience (FDA, EMA, or equivalent) preferred
• Direct communicator with the credibility to engage senior cross-functional stakeholders
Education
Bachelor's degree in a life sciences or related field required. Advanced degree a plus. CCDM certification viewed favorably.
Location & Schedule
Hybrid schedule with weekly on-site presence required. Candidates must reside within commuting distance or be open to relocation.
Qualifications
- •10+ years of clinical data management experience in pharma, biotech, or CRO settings
- •4+ years leading or managing CDM teams
- •Proven track record across multiple concurrent global trials, Phase I through III
- •Strong EDC platform experience (Medidata Rave or equivalent)
- •CDISC standards expertise — CDASH required, SDTM familiarity expected
- •Experience with multi-CRO oversight and risk-based monitoring models
- •Direct communicator with the credibility to engage senior cross-functional stakeholders
- •Bachelor's degree in a life sciences or related field required
- •CCDM certification viewed favorably
- •Candidates must reside within commuting distance or be open to relocation
Benefits
- •Hybrid schedule with weekly on-site presence required
Responsibilities
- •This is a hands-on leadership role with a hybrid schedule that includes required weekly on-site presence
- •Candidates must be able to commute to site on a weekly basis — remote-only arrangements will not be considered
- •End-to-end CDM accountability across Phase I–III studies, from database design through database lock
- •Build, manage, and develop a high-performing CDM team
- •Drive CRF design, data validation specifications, edit check development, and data management planning
- •Oversee CRO and CDM vendor performance — scope, timelines, quality, and escalation
- •Lead CDISC/CDASH standards implementation and ensure consistency across the portfolio
- •Serve as the CDM functional lead on cross-functional study teams alongside Biostatistics, Clinical Operations, and Regulatory
- •Ensure inspection readiness across all active studies; represent CDM in regulatory audits as needed
- •Partner with IT and systems teams on EDC platform management and optimization
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