Clinical Data Associate (12-month TERM)

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.

 

The Opportunity

In anticipation of the Company’s growth plans, Denali Therapeutics is seeking to recruit a Clinical Data Associate. The Clinical Data Associate 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 Associate 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)

Primary

• 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.

 

Other Responsibilities

• 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 agreement
• 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

 

Requirements

• 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 Manageme