Senior Clinical Trial Manager
New
A
Ascendis PharmaBiopharmaceutical
The role will be based in Palo Alto, CA or be remoteFull-TimeSenior
Salary$160-170K DOE
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Job Details
- Languages
- English
- Experience
- 7+ years of combined experience in managing/monitoring Phase 1, 2, or 3 clinical trials.
- 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 or equivalent work experience.
- Mastery knowledge of ICH-GCP, regulatory guidance, and SOP implementation.
- High proficiency in English with strong communication and presentation skills.
- Proficiency with Veeva Systems (Clinical Vault eTMF, Veeva EDC), CTMS, and Endpoint IRT.
- Proficiency with Microsoft Office (Outlook, Word, Excel, PowerPoint).
- Experience managing and overseeing clinical vendors.
- Experience in performing clinical site monitoring visits, including remote visits.
- Ability to work independently, manage timelines, and prioritize tasks.
- Ability to travel up to 20% of the time domestically for meetings and co-monitoring.
Responsibilities
- Foster and maintain clinical site and investigator relationships.
- Review monitoring reports for compliance with study protocols and ICH-GCP regulations.
- Generate and utilize metrics reporting from CTMS and EDC to monitor study health.
- Manage and support vendors including central laboratories, IRBs, and site payment systems.
- Maintain Trial Master File (TMF) and Investigator Site Files, including quarterly eTMF reviews.
- Coordinate study-specific training for internal teams and site staff.
- Accountable for audit preparation to assist sites and internal staff with GCP compliance.
- Facilitate EDC and IRT access for site and study teams.
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