Sr. Manager, Clinical Data Management (Lead)

The Senior Clinical Data Manager (CDM) will work in an outsourced data management model. The Sr. Manager will lead data management activities, will interface with the project team to ensure that data management services are delivered in a consistent, high-quality manner, and will provide input into CDM organizational strategy and implement department change. This individual will also independently perform/oversee tasks related to database and report setup, as well as processing and cleaning clinical trial data, following all applicable standard and study-specific procedures., * 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

• 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

Pulled from the full job description

• Employee stock purchase plan
• 401(k)
• Health insurance, Salary Range: $155,000.00 to $202,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.