Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. 

The Opportunity

The Clinical Trial Manager (CTM) is responsible managing the day-to-day operations of assigned clinical studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.  The CTM will work closely with a cross-functional team to ensure that clinical trials are conducted in a timely fashion and in compliance with Denali SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.

Responsibilities

  • Lead/support internal cross-functional study execution team for assigned stud(ies) and/or assigned stud(ies) region to identify risks and mitigations strategies.
  • Lead/support preparation of vendor requirements and project scope and selection of study vendors
  • Manage clinical research organizations to ensure timely and quality deliverables.
  • Manage and lead the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
  • Lead/support feasibility assessment and selection of countries and sites for study conduct.
  • Lead/support the development of study plans and system set-up and UAT and ensure operational excellence of protocol, CRF, CSR and other key study deliverables.
  • Implement appropriate systems, standards and processes to ensure quality at the level of investigative sites, vendors and data; maintain clinical study files per ICH guidance.
  • Oversee the quality of the clinical trial master files.
  • Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans.
  • Author, audit and/or edit written summaries of data reports, presentations, training material, and study documents (including pharmacy, laboratory, and operations manuals).
  • Ensure set-up and implementation of effective investigator and site monitor training
  • Create and conduct study-specific training at investigator meetings.
  • Review study invoices and participate in accrual reviews to track the financial status of the study against budget.
  • All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.

Requirements

  • Bachelor’s degree required. RN/PA with professional clinical experience, and/or Master’s degree or higher in health-related science or equivalent preferred.
  • 4+ years in a pharmaceutical setting (sponsor side experience a plus) with 2+ years of trial management experience required.
  • Excellent organizational skills and attention to detail.
  • Effective communication and interpersonal skills.
  • Ability to efficiently perform multiple tasks and manage changing priorities.
  • Ability to identify and solve logistical problems.
  • Demonstrate proficiency in Microsoft Word, PowerPoint and Excel.
  • Ability to build strong relationships with co-workers of various backgrounds and expertise.
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor.
  • Values-based leadership consistent with Denali's Core Values.
  • Excitement about the vision and mission of Denali.

#LI-SC1

 

 

Apply for this Job

* Required
  
(File types: pdf, doc, docx, txt, rtf)
  
(File types: pdf, doc, docx, txt, rtf)
When autocomplete results are available use up and down arrows to review
+ Add Another Education