Clinical Trial Manager
Salary undisclosed
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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. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the 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 Accountabilities/Core Job Responsibilities
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.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.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
Key Accountabilities/Core Job Responsibilities
- Lead/support: internal cross-functional study execution team for assigned stud(ies) and/or assigned stud(ies); preparation of vendor requirements and project scope and selection of study vendors.
- 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. This includes managing clinical research organizations to ensure timely and quality deliverables.
- Lead/support feasibility assessment and selection of countries and sites for study conduct, development of study plans, system set-up and UAT to 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 as well as 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.
- Ensure that all work adheres to ICH Good Clinical Practice (GCP) guidelines and comply with company SOPs.
- 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.
- 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.
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.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.
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
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