Senior Clinical Trial Manager

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 is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Vera Therapeutics’ flagship commercial product is TRUTAKNATM (atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand( APRIL) inhibitor. Vera Therapeutics is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Vera Therapeutics was founded in 2016 and is based in Brisbane, California. To learn more, visit www.veratx.com.

At Vera, our values are the cornerstone of our culture and guide how we work together every day. We lead with empathy, act with an owner’s mindset, demand clarity, work without fences, and execute with urgency because patients are counting on us. From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney.

Position Summary:

We are seeking a highly skilled and motivated Senior Clinical Trial Manager to join a fast-paced and collaborative team. The Senior 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 the GCP, protocol, SOPs and other key performance indicators (e.g., review of monitoring reports, study tracking tools, etc.) to ensure proper oversight of the CRO and sites.
• Proactively identifies potential study issues/risks and recommends/implements solutions.
• Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project files) and serves as the primary CRO/vendor contact.
• Supports the CRO to ensure quality and accurate data is generated and assists in resolving any issues (e.g., subject eligibility, deviations, etc.) .
• Manages 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.
• Prepares metrics and updates for Vera management.
• Organizes and leads clinical operational meetings.
• Organizes and leads study team meetings.
• Develop and maintain strong working relationships with principal investigators, key clinical opinion leaders and sites.
• May contribute to development of RFPs and participates in selection of CROs/vendors as well as review of any CRO budgets and /or change orders.
• Develop strong cross-functional relationships and exhibits leadership skills with counterparts to ensure efficient execution of clinical trial.
• Ensure site and CRO adherence with SOP, applicable regulations, GCP, and ICH guidelines.
• Contributes to the development and/or review of study plans, ICFs, site manuals, patient materials, CRF completion guidelines, system specifications, etc.
• Attend and/or present at Investigator Meetings as needed.
• May travel up to 30%, 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 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.

Vera Therapeutics Inc. is an equal-opportunity employer.

Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

For this role, the anticipated base pay range is

$130,000 - $190,000 USD

At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.

CA Privacy Notice

Applicants residing in California should review our California Privacy Notice for Employees, Job Applicants, and Contractors, which describes the categories of personal information we collect, how we use it, and your privacy rights under the California Consumer Privacy Act, as amended by the California Privacy Rights Act: https://veratx.com/ca-privacy/.