Vera Therapeutics, Inc. is a clinical-stage biotechnology company developing treatments for immunological kidney diseases. Its lead program, atacicept, is in Phase 2b and Phase 3 trials for IgA nephropathy (IgAN), alongside research into lupus nephritis and other immunologic conditions. The company’s work brings together clinical development, scientific research, and patient engagement, with a focus on improving care for people living with these diseases.
Senior Clinical Trial Manager, Remote US
Lead global clinical trial operations at Vera Therapeutics, coordinating CROs, sites, timelines, compliance, and cross-functional teams. This remote US role supports trial execution from start-up through close-out.
Америка Құрама Штаттары130 000 $ – 190 000 $ / жыл
ҚашықтанТолық жұмыс күніАға маманҚажетті Тіл: ағылшын тіліКлиникалық зерттеулерСипаттама
- Lead global clinical trial operations from start-up through conduct and close-out.
- Monitor assigned trials for compliance with GCP, protocols, SOPs, and performance indicators.
- Oversee CROs and clinical sites, serving as the main contact for CROs and vendors.
- Identify study issues and risks, then recommend or implement solutions.
- Help CROs deliver accurate, high-quality data and resolve study issues.
- Coordinate study timelines with company and cross-functional objectives.
- Help write, review, and finalize protocols and clinical study reports.
- Prepare trial metrics and updates for Vera management.
- Plan and lead clinical operations and study team meetings.
- Build relationships with principal investigators, clinical opinion leaders, and study sites.
- Support RFP development and CRO or vendor selection, and review CRO budgets and change orders.
- Build cross-functional partnerships and provide leadership for efficient trial delivery.
- Ensure CROs and sites follow SOPs, regulations, GCP, and ICH guidelines.
- Contribute to or review study plans, informed consent forms, site manuals, patient materials, CRF completion guidance, and system specifications.
- Attend or present at investigator meetings as needed.
- Travel up to 30% as needed to support clinical development programs.
Талаптар
- Bachelor’s degree or higher in a life sciences or health-related field.
- At least five years of clinical development experience, with progressive clinical research experience in the pharmaceutical or biotechnology industry.
- Experience in rare disease, inflammatory disease, or difficult-to-enroll studies is preferred.
- Regulatory filing experience and inspection readiness experience are preferred.
- Experience managing, mentoring, and developing junior staff.
- A flexible, self-directed approach suited to a fast-paced startup environment.
- Ability to develop creative solutions with limited infrastructure.
- Experience across all areas of clinical operations.
- Working knowledge of GCP, ICH guidelines, and FDA regulations.
- Ability to work independently and collaboratively on cross-functional teams.
- Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Project.
- Strong interpersonal skills and excellent oral and written communication.
- Innovative, analytical, and highly organized approach to completing projects.
Артықшылықтар
- Annual performance incentive bonus
- Equity for new hires
- Ongoing performance-based equity
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) match
- Flexible time off
- Paid holidays