Sr. Manager, Clinical Data Management (Lead)
Denali Therapeutics
August 12, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Key Accountabilities / Core Job Responsibilities:
- Provide clinical data management leadership as primary point of contact to align on and drive data collection requirements for one or more complex programs.
- Enforce data standard conventions and quality expectations; ensure compliance with applicable regulations and guidelines.
- Lead/support continuous improvement activities within CDM (SOP development, training, process mapping).
- Anticipate internal resource needs; partner with Head of CDM on contracting vs. FTE approaches.
- Review and approve key CDM deliverables (CRF design/completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specs, SAE reconciliation plans, medical coding, data listing specs, electronic data transfer agreements).
- Provide quality/project oversight over CROs for DM activities (review vendor proposals, budgets, scopes of work).
- Manage/oversee study setup, testing, and system validation for new studies with the DM vendor, including CRO-executed data cleaning.
- Develop/manage timelines for key CDM deliverables with the CDM CRO and project team.
- Communicate complex issues/solutions and escalate to senior management as needed.
- Coach and provide quality oversight of junior Data Management Leads; assist with QA findings and Health Authority inspections/audits.
Qualifications/Skills:
- Bachelor’s degree in mathematics, science, or health-related field; 10+ years clinical data management experience (biotech/pharma/health-related), including 3+ years coaching/oversight.
- CDM deliverable leadership across Phase 1–4 trials (including early-phase/dose-escalation).
- Knowledge of clinical drug development process and regulatory/data standards (ICH/FDA, CDISC CDASH/SDTM/ADaM, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, GDPR).
- Understanding of clinical trial database lifecycle (CRF design, development/testing, discrepancy management, data quality review, database lock).
- Proactive risk identification and strategic solutioning; strong interpersonal and communication skills.
- Strong analytical/problem-solving skills; ability to work independently and cross-functionally.
Benefits/Compensation:
- Salary range: $155,000.00 to $202,000.00.
- Competitive total rewards package including 401k, healthcare coverage, ESPP and other benefits.
Application Instructions:
- Learn more at https://www.denalitherapeutics.com/careers.
- Provide clinical data management leadership as primary point of contact to align on and drive data collection requirements for one or more complex programs.
- Enforce data standard conventions and quality expectations; ensure compliance with applicable regulations and guidelines.
- Lead/support continuous improvement activities within CDM (SOP development, training, process mapping).
- Anticipate internal resource needs; partner with Head of CDM on contracting vs. FTE approaches.
- Review and approve key CDM deliverables (CRF design/completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specs, SAE reconciliation plans, medical coding, data listing specs, electronic data transfer agreements).
- Provide quality/project oversight over CROs for DM activities (review vendor proposals, budgets, scopes of work).
- Manage/oversee study setup, testing, and system validation for new studies with the DM vendor, including CRO-executed data cleaning.
- Develop/manage timelines for key CDM deliverables with the CDM CRO and project team.
- Communicate complex issues/solutions and escalate to senior management as needed.
- Coach and provide quality oversight of junior Data Management Leads; assist with QA findings and Health Authority inspections/audits.
Qualifications/Skills:
- Bachelor’s degree in mathematics, science, or health-related field; 10+ years clinical data management experience (biotech/pharma/health-related), including 3+ years coaching/oversight.
- CDM deliverable leadership across Phase 1–4 trials (including early-phase/dose-escalation).
- Knowledge of clinical drug development process and regulatory/data standards (ICH/FDA, CDISC CDASH/SDTM/ADaM, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, GDPR).
- Understanding of clinical trial database lifecycle (CRF design, development/testing, discrepancy management, data quality review, database lock).
- Proactive risk identification and strategic solutioning; strong interpersonal and communication skills.
- Strong analytical/problem-solving skills; ability to work independently and cross-functionally.
Benefits/Compensation:
- Salary range: $155,000.00 to $202,000.00.
- Competitive total rewards package including 401k, healthcare coverage, ESPP and other benefits.
Application Instructions:
- Learn more at https://www.denalitherapeutics.com/careers.