Title: Clinical Trial Manager Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera's mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera's lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Position Summary: We seek a highly skilled and motivated Clinical Trial Manager to join a fast-paced and collaborative team. The Clinical Trial Manager will be responsible for the day-to-day operational oversight of assigned trial(s) in accordance with the protocol, standard operating procedures (SOPs) and GCP/ICH guidelines to support successful execution of the trial within timelines, budget and with the highest quality.
Responsibilities: Manage all clinical operational aspects of a global clinical trial including start-up, conduct and close out activities.Monitor assigned trial for adherence to the GCP, protocol, SOPs and other key performance indicators (e.g., review of monitoring reports, study tracking tools, etc.) to ensure proper oversight of the CRO and sites.Proactively identifies potential study issues/risks and recommends/implements solutions.Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project files) and serves as the primary CRO/vendor contact.Supports the CRO to ensure quality and accurate data is generated and assists in resolving any issues (e.g., subject eligibility, deviations, etc.).Contribute to the writing, review and finalization of protocols or components of clinical study reports.Prepares metrics and updates for Vera management.Organizes and leads clinical operational meetings.Develop and maintain strong working relationships with principal investigators, key clinical opinion leaders and sites.May contribute to development of RFPs and participates in selection of CROs/vendors as well as review of any CRO budgets and/or change orders.Develop strong cross-functional relationships and exhibits leadership skills with counterparts to ensure efficient execution of clinical trial.Ensure site and CRO adherence with SOP, applicable regulations, GCP, and ICH guidelines.Contributes to the development and/or review of study plans, ICFs, site manuals, patient materials, CRF completion guidelines, etc.Attend and/or present at Investigator Meetings as needed.May travel up to 15%, as needed, to support clinical development programs.Qualifications: BS or higher in life sciences or health-related field.5+ years clinical development experience and progressive experience in clinical research within the pharmaceutical or biotechnology industry.Rare disease and inflammatory diseases and/or difficult enrolling study experience preferred.Regulatory filing and experience with inspection readiness preferred.Experienced in managing, mentoring and developing junior staff.Flexible self-starter to operate in a fast-paced start-up environment.Ability to develop out of the box solutions with limited infrastructure.Experience in all aspects of clinical operations.Working proficiency of GCP, ICH guidelines and FDA regulations.Ability to work independently as well as collaboratively in cross-functional team environment.Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook, Project).Strong interpersonal skills with excellent oral and written communications.Innovative, analytical and extremely organized to drive projects to completion.
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