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.

Primary

Responsibilities (include but are not limited to the following)

• Deliver high quality data for analysis and study milestones.
• Serve as a data management expert and be the CDM support for assigned clinical studies on multidisciplinary project teams.

Other Responsibilities

• Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management vendor and Denali project team
• Oversee data cleaning activities executed by the DM vendor and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data
• Responsible for oversight of data transfers for assigned studies
• Monitor vendor performance to ensure timelines and data quality standards are met
• Ensure compliance of clinical data management processes with applicable regulations and guidelines
• Reviews protocols from a CDM perspective and provide functional-expert feedback
• 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
• Supports strategic initiatives for the clinical data management function
• Performs other duties as assigned
• 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
• Maintain and create standardized processes for data management activities
• Represent clinical data management in cross-functional meetings
• Ensure accurate development and execution of data integrations between databases such as EDC, LIMS, and other internal and external data sources
• Supports data management activities, systems, and processes across clinical studies supported by Clinical Data Management team
• Participate as needed in the preparation and presentation of data.
• Manage/oversee study setup, testing and system validation for new studies in partnership with the DM vendor
• Reviews trial protocols and assists in the planning and implementation of Data Management processes.
• 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
• Ensure data system compliance by following the established guidelines (e.g., FDA).
• Supports development and maintenance of Clinical Data Management-related SOPs, Work Instructions, and infrastructure

Requirements

• Experience on all study phases including early phase, dose escalation studies is greatly preferred
• Comprehensive experience working with clinical database systems
• Strong interpersonal skills and communication skills (both written and oral).
• Able to work in a fast paced and dynamic environment while effectively managing multiple projects which may have changing priorities
• CNS/Neurodegenerative trial experience is greatly preferred
• 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
• Strong analytical and problem-solving skills
• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
• 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
• Prior experience as a study lead data manager is a plus.

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: $117,000 to $141,000. 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

• 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.

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