Senior Clinical Trial Manager
New
A
Ascendis PharmaBiopharmaceutical
Palo Alto, California, United States or remoteFull-TimeSenior
Salary$160-170K DOE
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Job Details
- Languages
- English
- Experience
- 7+ years
- Required Skills
- Microsoft Office
Requirements
- 7+ years of combined experience in managing/monitoring Phase 1, 2, or 3 clinical trials.
- Bachelor’s or master’s degree in natural or health sciences preferred.
- Mastery knowledge of ICH-GCP and relevant regulatory guidance.
- Proficiency in English with strong communication and presentation skills.
- Experience managing and overseeing vendors.
- Experience performing clinical site monitoring visits, including remote visits.
- High proficiency with Veeva Systems (Clinical Vault eTMF, Veeva EDC), CTMS, and Endpoint IRT.
- Strong Microsoft Office skills (Outlook, Word, Excel, PowerPoint).
- Ability to prioritize work and manage timelines independently.
- Ability to travel up to 20% of the time domestically for meetings.
Responsibilities
- Foster and maintain clinical site and investigator relationships.
- Review monitoring reports for compliance to study protocols, regulations and ICH/GCP.
- Generate and utilize metric reporting to ensure study conduct per plans.
- Ensure accurate reporting of protocol deviations and track resolution.
- Manage Trial Master File and Investigator Site Files in Veeva Vault.
- Coordinate vendor management for central laboratories, IRB, and site payment systems.
- Conduct study team and monitoring meetings.
- Collaborate with clinical operations and data management to ensure data quality.
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