Denali Therapeutics brings the power of biotherapeutics to the whole body, including the brain. We discover, develop and deliver medicines for people living with serious diseases. Backed by GV.
About the role
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.
What they're looking for
- 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
- This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future
More about this role
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.
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,...
Browse similar: Startup jobs · San Francisco Bay Area