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About the Role

Denali Therapeutics is seeking a Senior Clinical Data Manager to lead data management activities in an outsourced model, ensuring high-quality data collection and contributing to organizational strategy. This role is crucial for delivering breakthrough therapies for neurodegenerative diseases.

Responsibilities

• Provide clinical data management leadership as the primary point of contact within the study team.
• Align on and drive data collection requirements for complex programs.
• Promote constructive and effective relations between team members.
• Enforce data standard conventions and quality expectations for clinical data per defined processes.
• Ensure compliance with applicable regulations and guidelines.
• Lead or support continuous improvement activities within CDM, including SOP development, training, and process mapping.
• Anticipate internal resource needs and work with the Head of CDM on appropriate approaches.
• Review and approve key clinical data management deliverables.
• Provide quality and project oversight over CROs responsible for DM activities.
• Manage/oversee study setup, testing, and system validation for new studies in partnership with the DM vendor.
• Develop and manage timelines for key clinical data management deliverables.
• Keep team members fully apprised of complex issues and solutions.
• Escalate issues to senior management as needed.
• Provide coaching and quality oversight of junior Data Management Leads.
• Assist with responses to QA findings and Health Authority inspections/audits.

Requirements

• Typically requires a Bachelor's degree in mathematics, science, or a health-related field.
• Minimum of 10 years of clinical data management experience in biotech, pharmaceutical, or health-related industries.
• Includes 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.

Skills

• Clinical Data Management
• Biotech/Pharmaceutical Industry Experience
• Leadership
• Project Management
• Regulatory Compliance
• SOP Development
• Process Improvement
• Vendor Oversight
• Database Setup and Validation
• Timeline Management
• Coaching
• Quality Oversight
• Risk Identification
• Problem-Solving
• Interpersonal Skills
• Communication Skills
• Analytical Skills
• CDISC Standards (CDASH, SDTM, ADaM)
• GCDMP
• 21 CFR 11
• MedDRA
• WHO Drug Dictionaries
• GDPR

Location

• Remote

Work Type

• Full-time

Experience Level

• Senior
• 10+ years of clinical data management experience
• 3+ years of coaching/oversight experience

Education Level

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

Salary/Compensations

• $155,000.00 to $202,000.00

Benefits

• 401k
• Healthcare coverage
• ESPP

About the Company

• Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases.
• The company is founded on the collaboration of leading scientists, industry experts, and investors.
• Denali is committed to its core company value of unity by creating a diverse and inclusive environment.

Equal Opportunity

• Denali is proud to be an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.