Drives the operational execution of assigned clinical studies from study start-up through closeout to ensure delivery of quality clinical data within established timelines and budgets. Partners cross-functionally with Clinical Operations, Data Management, Biostatistics, Medical, Regulatory, and external vendors to support efficient study conduct and regulatory compliance. Applies clinical trial management expertise to resolve operational issues, manage vendors, and ensure adherence to ICH/GCP guidelines, company SOPs, and applicable regulatory requirements. Contributes to continuous improvement initiatives that enhance study execution and operational effectiveness.
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 to support effective trial execution.
- 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 to address issues impacting quality, timelines, or budget.
- Contribute to data review, data cleaning activities, and operational review of study outputs and clinical study documentation.
- Prepare and review study-related materials including training content, operational manuals, presentations, and status reports.
- Review study invoices, support accrual tracking activities, and monitor study spend against approved budgets.
Qualifications/Skills:- Typically requires a bachelor's degree in life sciences, nursing, health sciences, or a related field; advanced degree, RN, or PA credentials preferred.
- Typically requires 5+ years of clinical research or pharmaceutical industry experience, including 2+ years of clinical trial management experience.
- Experience managing global or multi-site clinical studies within a sponsor or CRO environment preferred.
- Working knowledge of ICH/GCP guidelines, FDA regulations, and clinical trial processes across study start-up, conduct, and closeout.
- Demonstrated ability to manage multiple priorities, solve operational issues, and drive projects 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.
Salary Range: $139,000.00 to $180,000.00 . Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
This compensation and benefits information is based on Denali's good faith estimate as of the date of publication and may be modified in the future.
