What are the responsibilities and job description for the Associate Director, Clinical Data Management position at Denali Therapeutics Inc?
South San Francisco, California
Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degenerative biology and the principles of translational medicine.
The Opportunity
Denali Therapeutics, Inc. seeks an Associate Director, Clinical Data Management for its South San Francisco, California location.
Responsibilities
Lead and manage the execution of data management activities for more than one molecule in an assigned therapeutics area. Monitor and perform Clinical Data Management (CDM) activities across a therapeutic area. Make strategic recommendations on the CDM organizational and implement departmental process changes. Create, review, and approve key clinical data management deliverables. Oversee and manage DM CRO and vendors including study setup, testing, and system validation protocols for the assigned program or studies. Direct data cleansing activities executed by the CRO and ensure that protocol-specified guidelines are properly followed in the clinical data review and cleaning processes. Deliver high quality data for analysis and to meet study milestones. Collaborate with internal cross-functional teams including Data Science, Biostatistics, and Medical Monitor to identify critical variables in the clinical dataset, for protocol-specified endpoints. Coordinate implementing these variables into CRO DM activities. Lead internal data reviews with cross-functional teams periodically after the clinical database after go-live until final database lock. Lead the development, review, and implementation of processes, policies, SOPs, and associated documents affecting CDM. Ensure CDM practice’s compliance with, and adherence to, regulatory rules and guidelines. Telecommute allowed 5 days per week from any lower 48 states within the US.
Required qualifications
Bachelor’s degree, or foreign degree equivalent, in Mathematics, Science, Engineering, or closely related fields, and 10 years of post-baccalaureate and progressive experience as Project Data Manager, Service Delivery Manager, Associate, Team Leader, Senior Manager Clinical Data Management, Program Lead Clinical Data Management, or closely related job in clinical data management arena across phase 1- 3 clinical trials. Employer will accept 3-year Bachelor’s degree. Alternatively, will also accept a Master’s degree, or foreign degree equivalent, in Mathematics, Science, Engineering, or closely related fields, and 8 years of experience as Project Data Manager, Service Delivery Manager, Associate, Team Leader, Senior Manager Clinical Data Management, Program Lead Clinical Data Management, Senior Data Scientist or closely related job in clinical data management arena across phase 1- 3 clinical trials.
Clinical Data Management Process
Project Management in clinical studies
Medidata Rave (Electronic Database Capture System)
Management of external data
Drug development regulatory guidelines and industry standards including the following, and their applications to Data Management practice: ICH/FDA guidance; CDISC standards including CDASH, SDTM and ADaM; GCDMP; 21CFR 11; MedDRA; WHO Drug Dictionaries; and data privacy regulations such as GDPR.
Telecommute allowed 5 days per week from any lower 48 states within the US.
Salary Range: $ 204,000 to $ 210,000. 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.
Salary : $204,000 - $210,000
