Clinical Trial Manager
Denali Therapeutics
12 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Key Accountabilities / Core Job Responsibilities
- Manage day-to-day operational execution of assigned clinical studies to achieve study milestones, quality expectations, and budget objectives.
- May lead cross-functional study team activities and coordinate operational deliverables across internal stakeholders and external vendors.
- Oversee CROs and study vendors to ensure timely delivery, issue resolution, quality performance, and compliance with study requirements.
- Support study start-up activities including feasibility assessments, country and site selection, vendor selection, system set-up, and user acceptance testing.
- Develop and maintain study management plans, operational timelines, and study tracking tools.
- Ensure inspection readiness and maintain Trial Master File documentation in compliance with ICH/GCP guidelines and company SOPs.
- Monitor study progress, identify operational risks, and implement mitigation plans.
- Contribute to data review, data cleaning activities, and operational review of study outputs and clinical documentation.
- Prepare and review study-related materials including training content, operational manuals, presentations, and status reports.
- Review study invoices, support accrual tracking, and monitor study spend against approved budgets.
Qualifications/Skills
- Bachelor’s degree in life sciences, nursing, health sciences, or related field; advanced degree, RN, or PA preferred.
- 5+ years clinical research or pharmaceutical industry experience; 2+ years clinical trial management experience.
- Experience managing global/multi-site clinical studies (sponsor or CRO) preferred.
- Working knowledge of ICH/GCP, FDA regulations, and end-to-end clinical trial processes.
- Ability to manage multiple priorities, solve operational issues, and work independently in a fast-paced environment.
- Strong organizational, communication, and cross-functional collaboration skills.
- Proficiency with clinical trial systems, study tracking tools, and vendor management processes.
Benefits/Compensation
- Salary range: $139,000.00 to $180,000.00; competitive total rewards package including 401k, healthcare coverage, and ESPP.
Application instructions
- Learn more at https://www.denalitherapeutics.com/careers
- Manage day-to-day operational execution of assigned clinical studies to achieve study milestones, quality expectations, and budget objectives.
- May lead cross-functional study team activities and coordinate operational deliverables across internal stakeholders and external vendors.
- Oversee CROs and study vendors to ensure timely delivery, issue resolution, quality performance, and compliance with study requirements.
- Support study start-up activities including feasibility assessments, country and site selection, vendor selection, system set-up, and user acceptance testing.
- Develop and maintain study management plans, operational timelines, and study tracking tools.
- Ensure inspection readiness and maintain Trial Master File documentation in compliance with ICH/GCP guidelines and company SOPs.
- Monitor study progress, identify operational risks, and implement mitigation plans.
- Contribute to data review, data cleaning activities, and operational review of study outputs and clinical documentation.
- Prepare and review study-related materials including training content, operational manuals, presentations, and status reports.
- Review study invoices, support accrual tracking, and monitor study spend against approved budgets.
Qualifications/Skills
- Bachelor’s degree in life sciences, nursing, health sciences, or related field; advanced degree, RN, or PA preferred.
- 5+ years clinical research or pharmaceutical industry experience; 2+ years clinical trial management experience.
- Experience managing global/multi-site clinical studies (sponsor or CRO) preferred.
- Working knowledge of ICH/GCP, FDA regulations, and end-to-end clinical trial processes.
- Ability to manage multiple priorities, solve operational issues, and work independently in a fast-paced environment.
- Strong organizational, communication, and cross-functional collaboration skills.
- Proficiency with clinical trial systems, study tracking tools, and vendor management processes.
Benefits/Compensation
- Salary range: $139,000.00 to $180,000.00; competitive total rewards package including 401k, healthcare coverage, and ESPP.
Application instructions
- Learn more at https://www.denalitherapeutics.com/careers