What are the responsibilities and job description for the Manager, Clinical Data Management position at Denali Therapeutics Inc?
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.
Key Accountabilities/Core Job Responsibilities:
Serve as a data management expert and 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 review plans, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, data transfer specifications, and electronic data transfer specifications
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
Lead direct report(s), if applicable, through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
Qualifications/Skills:
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
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.
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.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.
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 : $135,000 - $166,667
