Clinical Trial Manager
Vor 5 Tagen
**Clinical Trial Manager**
***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 logístical 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.
- This position will be based in Zurich, Switzerland.
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