Senior Clinical Trial Manager

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $130k - $190k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Vera Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Vera Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments for immunological kidney diseases that improve patients’ lives. The company is advancing Atacicept through clinical development for IgA nephropathy (IgAN), running Phase 2b and Phase 3 trials, and pursuing programs in lupus nephritis and other immunologic conditions. Headquartered in Brisbane, CA, Vera emphasizes science-driven drug development, patient engagement, and sustainability.

📋 Description

• Manage all clinical operational aspects of a global clinical trial, including start-up, conduct, and close-out activities • Monitor assigned trials for adherence to GCP, protocols, SOPs, and key performance indicators • Oversee CROs and clinical sites and serve as the primary CRO/vendor contact • Identify study issues and risks and recommend or implement solutions • Support CROs in generating quality, accurate data and resolving issues • Manage study timelines in alignment with corporate and cross-functional goals • Contribute to writing, reviewing, and finalizing protocols and clinical study reports • Prepare metrics and updates for Vera management • Organize and lead clinical operational and study team meetings • Develop relationships with principal investigators, clinical opinion leaders, and sites • Contribute to RFP development, CRO/vendor selection, and review of CRO budgets or change orders • Develop cross-functional relationships and provide leadership to ensure efficient trial execution • Ensure site and CRO adherence to SOPs, regulations, GCP, and ICH guidelines • Contribute to or review study plans, ICFs, site manuals, patient materials, CRF completion guidelines, and system specifications • Attend or present at Investigator Meetings as needed • Travel up to 30% as needed to support clinical development programs

🎯 Requirements

• 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 (Word, Excel, PowerPoint, Outlook, Project) • Strong interpersonal skills with excellent oral and written communications • Innovative, analytical, and extremely organized to drive projects to completion

🏖️ Benefits

• Annual performance incentive bonus • New hire equity • Ongoing performance-based equity • Medical insurance • Dental insurance • Vision insurance • 401(k) match • Flexible time off • Paid holidays