Senior Clinical Trial Manager (CTM)

Denali Therapeutics; South San Francisco (CA); On-site; USD 154,000 - 196,000; Full time

Job summary

A leading biotechnology company in South San Francisco is seeking a Senior Clinical Trial Manager to oversee clinical trial operations. The role involves managing study conduct, ensuring compliance with regulatory requirements, and leading cross-functional teams. Candidates should have a relevant degree and significant experience in trial management. Denali Therapeutics offers a competitive salary and comprehensive benefits package.

Benefits

401k

Healthcare

ESPP

Qualifications

• 5+ years in a pharmaceutical setting with at least 3 years of trial management experience.
• Values-based leadership aligned with Denali's core values.

Responsibilities

• Manage study operations ensuring compliance with GCP/ICH guidelines.
• Lead cross-functional study execution teams and oversee vendors.
• Prepare vendor requirements and manage study documentation.

Skills

Organizational Skills

Communication

Interpersonal Skills

Education

Bachelor’s Degree

Master’s Degree in Health-Related Sciences

Tools

Microsoft Office

Job description

Join to apply for the Senior Clinical Trial Manager (CTM) role at Denali Therapeutics.

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Founded by leading scientists, industry experts, and investors, our vision is that scientific discovery applied to translational medicine is key to delivering effective therapies to patients.

We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.

Key Responsibilities

• Manage the full scope of study conduct, coordinating cross-functional efforts and overseeing vendors to ensure timely, quality deliverables in compliance with GCP/ICH guidelines and regulatory requirements.
• Lead cross-functional study execution teams, ensuring operational excellence, risk mitigation, and adherence to budget and corporate goals.
• Prepare vendor requirements and project scope, select study vendors, and oversee clinical research organizations.
• Manage study operations to ensure completion per project goals and regulatory compliance.
• Implement systems and standards to ensure quality at investigative sites, vendors, and data management.
• Oversee clinical trial documentation, data quality, and analysis, participating in data reviews and statistical analysis plan reviews.
• Author and edit study reports, presentations, training materials, and manuals.
• Coordinate investigator and site monitor training, including study-specific training at investigator meetings.
• Review study invoices and track financial status against budget.
• Ensure adherence to ICH GCP guidelines and company SOPs.

Qualifications

• Bachelor’s degree required; RN/PA or Master’s degree in health-related sciences preferred.
• 5+ years in a pharmaceutical setting with at least 3 years of trial management experience.
• Strong organizational, communication, and interpersonal skills.
• Proficiency in Microsoft Office suite.
• Ability to manage multiple priorities and build strong collaborative relationships.
• Values-based leadership aligned with Denali's core values.
• Excitement about Denali’s mission and vision.

Salary Range: $154,000 - $195,333. Denali offers a comprehensive rewards package including 401k, healthcare, ESPP, and other benefits. Learn more at our careers page.

Denali is committed to diversity and inclusion. We are an equal opportunity employer and do not discriminate based on race, color, sex, age, national origin, religion, sexual orientation, gender identity, veteran status, disability, or any other protected class.