Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.
In anticipation of the Company’s growth plans, Denali Therapeutics is seeking to recruit a Clinical Data Manager. The Clinical Data Manager will work in an outsourced data management model. He or she will participate in developing the 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. The Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with moderate guidance.
Responsibilities (include but are not limited to the following)
Serve as a data management expert and be the CDM support 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
Supports data management activities, systems, and processes across clinical studies supported by Clinical Data Management team
Supports development and maintenance of Clinical Data Management-related SOPs, Work Instructions, and infrastructure
Supports strategic initiatives for the clinical data management function
Maintain and create standardized processes for data management activities
Represent clinical data management in cross-functional meetings
Reviews trial protocols and assists in the planning and implementation of Data Management processes.
Participate in study document reviews (e.g., clinical study protocols, statistical analysis plans)
Work cross-functionally with other functions to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting
Responsible for oversight of data transfers for assigned studies
Participate as needed in the preparation and presentation of data.
Ensure accurate development and execution of data integrations between databases such as EDC, LIMS, and other internal and external data sources
Ensure data system compliance by following the established guidelines (e.g., FDA)
Performs other duties as assigned
BA/BS or higher preferably in math, science or health-related field with a minimum of 2+ years of experience in clinical data management across phase 1- 3 clinical trials
Prior experience as a study lead data manager is a plus.
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
Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice
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
Strong interpersonal skills and communication skills (both written and oral).