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 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). Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus. For more information, please visit: www.veratx.com.
Position Summary: Vera Therapeutics Inc. is seeking 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 GCP, protocol, SOPs, and other key performance indicators to ensure proper oversight of the CRO and sites.Proactively identify potential study issues/risks and recommend/implement solutions.Manage CRO interactions, including sponsor oversight of operational functional activities and serve as the primary CRO/vendor contact.Support the CRO to ensure quality and accurate data is generated and assist in resolving any issues.Contribute to the writing, review, and finalization of protocols or components of clinical study reports.Prepare metrics and updates for Vera management.Organize and lead clinical operational meetings.Develop and maintain strong working relationships with principal investigators, key clinical opinion leaders, and sites.Contribute to the development of RFPs and participate in selection of CROs/vendors as well as review of any CRO budgets and/or change orders.Develop strong cross-functional relationships and exhibit leadership skills with counterparts to ensure efficient execution of clinical trials.Ensure site and CRO adherence with SOP, applicable regulations, GCP, and ICH guidelines.Contribute 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 a 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.Vera Therapeutics Inc. is an equal-opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices. The anticipated base pay range for this role is $119,000 - $140,000, depending on various factors including geography, qualifications, skills, and experience. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity, along with various benefits offerings.
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