Senior Clinical Trial Manager

The role

The Senior Clinical Trial Manager provides day-to-day operational oversight of assigned clinical trials. This role ensures execution within timelines, budget, and quality standards in accordance with protocols, SOPs, and GCP/ICH guidelines.

What you will do

• 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.
• Identify potential study issues/risks and recommend/implement solutions.
• Manage CRO interactions and serve as the primary CRO/vendor contact.
• Support the CRO to ensure quality and accurate data is generated.
• Manage study timelines to align with corporate and cross-functional goals.
• 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 and study team meetings.
• Develop and maintain relationships with principal investigators, key clinical opinion leaders and sites.

Required 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.
• Experienced in managing, mentoring, and developing junior staff.
• Flexible self-starter to operate in a fast-paced start-up environment.
• Experience is 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.

Nice to have

• Rare disease and inflammatory diseases and/or difficult enrolling study experience
• Regulatory filing and experience with inspection readiness

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401k match
• Flexible time off
• Paid holidays

Before you apply

• May travel up to 30%, as needed, to support clinical development programs.

About the company

Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. The company was founded in 2016 and is based in Brisbane, California.