Senior Clinical Data Manager Lead, CRO Oversight

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

Benefits offered by this job

401k

healthcare coverage

ESPP

broad range of other benefits

Job summary

Denali Therapeutics Inc is seeking a Senior Clinical Data Manager to lead data management activities in an outsourced model. The role interfaces with the project team to ensure high-quality data management and informs CDM organizational strategy.

Responsibilities include overseeing database setup, data cleaning, and providing input into study-level deliverables and vendor management. The position requires strong leadership, extensive CDM experience across Phases 1-4, and expertise in ICH/FDA,

Qualifications

• Bachelor’s degree in science/health field with 10+ years CDM experience.
• Experience leading CDM deliverables across Phase 1-4 trials.
• Solid understanding of regulatory/data standards (ICH/FDA, CDISC, GDPR).
• Strong communication and problem-solving skills.

Responsibilities

• Provides clinical data management leadership as primary point of contact within the study team to align on data collection requirements.
• 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 (contracting vs. FTE).
• Reviews and approves key CDM deliverables (CRF design, database design specs, data entry guidelines, DM plans, edit checks, SAE reconciliation, medical coding, data listings, 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 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 CDM deliverables in coordination with the CDM CRO and Denali project team.
• Keeps team members apprised of complex issues and solutions; 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

Regulatory Knowledge

Data Standards (CDISC, SDTM, ADaM)

Cross-functional Collaboration

Quality Oversight

Education

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

10+ years clinical data management experience

Coaching/oversight experience for junior Data Management Leads

Job description

Denali Therapeutics Inc is seeking a Senior Clinical Data Manager to lead data management activities in an outsourced model. The role interfaces with the project team to ensure high-quality data management and informs CDM organizational strategy.

Responsibilities include overseeing database setup, data cleaning, and providing input into study-level deliverables and vendor management. The position requires strong leadership, extensive CDM experience across Phases 1-4, and expertise in ICH/FDA,