Senior Clinical Data Manager (12-month TERM)
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
TERM employee' means a project-specific employee holding a position for the time period specified above [OR: for 12 months], with a projected discharge date which may be adjusted according to funding limitations or completion of work. Employees hired to fill a TERM position enjoy all the benefits of a regular employee, including 401k, healthcare coverage, and ESPP, with the exception of equity grants and employment protection beyond the life of the designated project(s).
In anticipation of the Company’s growth plans, Denali Therapeutics is seeking to recruit a Senior Clinical Data Manager. The Senior Clinical Data Manager will work in an outsourced data management model. He or she will develop strategy, lead data management activities and will interface with the project team to ensure that data management services are delivered in a consistent, high-quality manner. 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.
Responsibilities (include but are not limited to the following)
- Serve as a data management expert and, if assigned, be the CDM lead for assigned clinical studies on multidisciplinary project teams.
- Deliver high quality data for analysis and study milestones.
- Reviews protocols from a CDM perspective and provide functional-expert feedback
- Review and approve key clinical data management deliverables generated by a DM vendor, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, and electronic data transfer agreements
- Manage/oversee study setup, testing and system validation for new studies in partnership with the DM vendor
- Oversee data cleaning activities executed by the DM vendor and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data
- Collaborate with internal Data Science (statistical programming), internal Biostatistics, and internal Medical Monitor on identifying critical variables in the clinical dataset, for protocol-specified endpoints. Coordinate implementing these variables into DM vendor activities
- Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management vendor and Denali project team
- Monitor vendor performance to ensure timelines and data quality standards are met
- Ensure compliance of clinical data management processes with applicable regulations and guidelines
- BA/BS or higher preferably in math, science or health-related field with a minimum of 5+ years of experience in clinical data management across phase 1- 3 clinical trials
- At least 5 years of the overall experience acting as a study lead data manager. Experience on all study phases including early phase, dose escalation studies is greatly preferred
- CNS/Neurodegenerative trial experience is greatly preferred
- Comprehensive experience working with clinical database systems
- Working knowledge of CDISC including CDASH, TAUG and SDTM as well as data privacy regulations e.g. GDPR
- Able to work in a fast paced and dynamic environment while effectively managing multiple projects which may have changing priorities
- Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
- Clear verbal and written communication skills
- Strong analytical and problem-solving skills
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do 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.
Salary Range: $130,000 to $160,667. 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
*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.