Senior Clinical Trial Manager – Global, Fast-Paced Biotech

Vera Therapeutics, Inc.; United States; Remote; USD 130,000 - 190,000; Full time

Benefits offered by this job

Annual performance incentive bonus

New hire equity

Medical, dental, and vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Vera Therapeutics in Brisbane, CA, seeks a Senior Clinical Trial Manager to oversee global clinical trials from start-up to close-out, ensuring adherence to protocol, SOPs, GCP/ICH, and timelines. You will manage CRO interactions, data quality, and study budgets, while mentoring junior staff and coordinating cross-functional teams.

The role requires 5+ years in clinical development, experience with rare or inflammatory diseases, and strong MS Office skills.

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.
• Working proficiency of GCP, ICH guidelines and FDA regulations.
• Experience working independently as well as in cross-functional teams.
• 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.

Responsibilities

• Manage all clinical operational aspects of a global clinical trial from start-up, conduct and close out activities.
• Monitor trial adherence to GCP, protocol, SOPs and KPIs to ensure proper oversight of CRO and sites.
• Identify potential study issues/risks and implement solutions.
• Manage CRO interactions and sponsor oversight of operational activities.
• Support CRO to ensure quality data and assist in resolving issues.
• Manage study timelines to align with corporate and cross-functional goals.
• Contribute to 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 and study team meetings.
• Develop relationships with investigators and sites; participate in CRO/vendor selection and budgeting reviews.
• Travel up to 30% as needed.

Skills

Clinical development

Project management

Cross-functional collaboration

Communication

Education

BS in life sciences

Tools

MS Office

Job description

Vera Therapeutics in Brisbane, CA, seeks a Senior Clinical Trial Manager to oversee global clinical trials from start-up to close-out, ensuring adherence to protocol, SOPs, GCP/ICH, and timelines. You will manage CRO interactions, data quality, and study budgets, while mentoring junior staff and coordinating cross-functional teams.

The role requires 5+ years in clinical development, experience with rare or inflammatory diseases, and strong MS Office skills.