Senior CDM Lead: Data Integrity & Study Delivery

Denali Therapeutics; South San Francisco (CA); Hybrid; USD 155,000 - 202,000; Full time

Benefits offered by this job

401k

Healthcare coverage

ESPP

Job summary

Denali Therapeutics in South San Francisco, CA, seeks a Senior Clinical Data Manager (Lead) to oversee data management activities in an outsourced model, driving high-quality CDM deliverables across complex programs.

You will lead CRO engagements, shape CDM strategy, mentor junior leads, and partner with study teams to ensure data integrity through CRF design, database setup, and data cleaning in compliance with ICH/FDA and CDISC standards.

Qualifications

• Typically requires a Bachelor's degree in mathematics, science, or a health-related field and a minimum of 10 years of clinical data management experience in biotech, pharmaceutical, or health-related industries, including 3+ years of coaching/oversight experience for junior Data Management Leads.
• Demonstrated proficiency leading CDM deliverables across Phase 1–4 clinical trials, including early-phase and dose-escalation studies.
• Solid understanding of the clinical drug development process and regulatory/data standards (ICH/FDA, CDISC — CDASH, SDTM, ADaM — GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, GDPR).
• Demonstrated understanding of the clinical trial database life cycle, including CRF design, development/testing, discrepancy management, data quality review, and database lock.
• Capable of proactively identifying project risks and proposing strategic solutions; excellent multi-disciplinary interpersonal and communication skills.
• Strong analytical and problem-solving skills; able to work independently and within cross-functional project teams.

Responsibilities

• Provides clinical data management leadership as primary point of contact within the study team to align on and drive data collection requirements for one or more complex programs; promotes constructive, effective relations between team members.
• Enforces data standard conventions and quality expectations for clinical data per defined processes; ensures compliance with applicable regulations and guidelines.
• Leads or supports continuous improvement activities within CDM, including SOP development, training, and process mapping.
• Anticipates internal resource needs and works with the Head of CDM on appropriate approaches (e.g., contracting vs. FTE).
• Reviews and approves key clinical data management deliverables (CRF design/completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, SAE reconciliation plans, medical coding, data listing specifications, electronic data transfer agreements).
• Provides quality and project oversight over CROs responsible for DM activities, including review of vendor proposals, budgets, and scopes of work
• Manages/oversees study setup, testing, and system validation for new studies in partnership with the DM vendor, including CRO-executed data cleaning activities.
• Develops and manages timelines for key clinical data management deliverables in coordination with the CDM CRO and Denali project team.
• Keeps team members fully apprised of complex issues and solutions in a timely, professional manner; escalates to senior management as needed.
• Provides coaching and quality oversight of junior Data Management Leads; assists with responses to QA findings and Health Authority inspections/audits

Skills

CDM leadership

Phase 1–4 trials

Regulatory/data standards

Cross-functional teamwork

Analytical/problem solving

Education

Bachelor's degree in mathematics, science, or health-related field

Job description

Denali Therapeutics in South San Francisco, CA, seeks a Senior Clinical Data Manager (Lead) to oversee data management activities in an outsourced model, driving high-quality CDM deliverables across complex programs.

You will lead CRO engagements, shape CDM strategy, mentor junior leads, and partner with study teams to ensure data integrity through CRF design, database setup, and data cleaning in compliance with ICH/FDA and CDISC standards.