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Clinical Systems Administrator

Company: Chinook Therapeutics
Location: Berkeley
Posted on: May 10, 2022

Job Description:

Job DescriptionSalary: Company: Chinook Therapeutics is a clinical-stage biotechnology company developing precision medicines for kidney diseases. Chinook's product candidates are being investigated in rare, severe chronic kidney disorders with opportunities for well-defined clinical pathways. Chinook's lead program is atrasentan, a phase 3 endothelin receptor antagonist for the treatment of IgA nephropathy and other proteinuric glomerular diseases. BION-1301, an anti-APRIL monoclonal antibody is being evaluated in a phase 1/2 trial for IgA nephropathy. In addition, Chinook is advancing CHK-336, an oral small molecule LDHA inhibitor for the treatment of primary hyperoxaluria, as well as research programs for other rare, severe chronic kidney diseases. Chinook is building its pipeline by leveraging insights in kidney single cell RNA sequencing, human-derived organoids, and new translational models, to discover and develop therapeutics with differentiating mechanisms of action against key kidney disease pathways. Chinook trades on Nasdaq under the ticker symbol KDNY and has locations in Vancouver, BC, Seattle, WA and Oakland, CA.Position: The Clinical Systems Administrator supports administration of Trial Master Files (TMF) and/or the Clinical Trial Management System (CTMS) across the Chinook portfolio. The Clinical Systems Administrator collaborates with Study Team(s) to initiate study set up, supports build out, manages systems access, conducts systems training and onboarding, and provides ongoing support to users throughout the life cycle of the study. This position will report to the Manager, Clinical Systems or above and may be remote or office based in Seattle, Oakland, or Vancouver, BC. Responsibilities include:

  • Administer Veeva eTMF and/or CTMS and perform daily system maintenance activities, including:
      • Manage controlled access
      • Support management of the full life cycle of TMF/CTMS activities from study initiation, through study execution, closure, to archival, contacts management, document processing, tracking and dashboarding, etc.
      • Perform routine document quality control per ALCOA+C and any specific company-defined requirements
      • Identify issues, risks, and trends (e.g., retraining opportunities) related to systems use
        • Provide initial and ongoing training to systems users in a manner highly responsive to trainee needs (department and role)
            • Be available for ad-hoc, regular and general support to trainees and users
              • Partner with the Manager, Clinical Systems to create and maintain internally controlled documents and other resources/tools related to TMF/CTMS use, e.g., SOPs, work instructions, training materials, and forms
              • Carry out system activities as assigned such as change requests, system upgrades, validation testing, and simple customization within the system
              • Maintain and support ongoing development of reports and dashboards, including TMF health and associated KPIs
              • When problems arise, help determine causes, and in collaboration with Manager, Clinical Systems and relevant stakeholders, initiate corrective and preventative action as appropriate
              • Work proactively to address business and people needs as well as system-related issues
              • Actively increase knowledge, understanding, and expertise in TMF/CTMS management and related global regulations
              • Contribute to the development and maintenance of a positive team-focused company cultureEducation, Experience, and Skills:
                • Bachelor's degree or above or equivalent experience
                • At least 4 years industry experience and at least 4 years supporting clinical systems in a biotech/pharmaceutical company
                • Progressive responsibility/experience maintaining TMF, utilizing CTMS, developing SOPs, analyzing business processes, and executing clinical records management procedures, including oversight activities
                • Broad understanding of business processes across a clinical development organization
                • Experience with eTMF and CTMS architecture and strong working knowledge of the TMF Reference model
                • Experience supporting CTMS integrations with TMF and/or other systems such as EDC
                • Strong working knowledge of GCP ICH, 21 CRF Part 11, HIPAA
                • Aware of data protection laws and the implications for TMF/CTMS as relevant to global trials
                • Comfortable shifting priorities and direction in a rapidly evolving landscape
                • Experience successfully training others to the use of clinical systems use
                • A team player as well as a strong independent contributor
                • Eager to grow and develop
                • Inspection experience a plusChinook is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind. We are committed to fostering an environment where ALL people are welcome and supported. We respect and value different experiences and viewpoints. We act respectfully toward one another and embrace diversity of people and ideas. Having a diverse workforce made up of team members who bring a wide variety of skills, abilities, experiences, and perspectives is essential to our success. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

Keywords: Chinook Therapeutics, Berkeley , Clinical Systems Administrator, IT / Software / Systems , Berkeley, California

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