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Ascendis Pharma, a global biopharmaceutical company with locations in Denmark, Europe, and the United States, is seeking a Senior Clinical Trial Manager to oversee the effective conduct of global and regional clinical trials. Based in Palo Alto, CA (with remote flexibility), this role reports to the Director of Clinical Operations and serves as a key member of cross-functional teams driving clinical trials to completion on schedule and to quality standards.
Key responsibilities include fostering and maintaining clinical site and investigator relationships; planning and conducting investigator meetings; reviewing monitoring reports for protocol compliance and regulatory adherence; generating and utilizing metric reporting (CTMS, DM Query Trends) to track study progress; ensuring accurate reporting and follow-up of protocol deviations; conducting monitoring meetings with agendas and minutes; coordinating study-specific training for internal and site teams; maintaining Trial Master Files and Investigator Site Files in Veeva Vault with quarterly reviews; managing vendor relationships for central laboratory, IRB, imaging, and patient services; facilitating EDC and IRT access; supporting CRA transitions; running study team meetings; reviewing site information and informed consents; assisting with GCP audit preparation; maintaining CTMS with site contacts, milestones, and regulatory submissions; escalating CRA performance and site compliance issues; collaborating on data quality and cleaning timelines; assisting with supply, sample, and IMP tracking; reviewing vendor data clarification forms; prioritizing and escalating issues; potentially developing clinical documents (protocols, ICF templates, CRFs, training materials); managing clinical vendors in conjunction with leadership; and conducting clinical data reviews.
The ideal candidate holds a Bachelor's or Master's degree in natural or health sciences (biology, pharmacology, pharmaceutical sciences) or equivalent work experience. Mastery knowledge of ICH-GCP, Ascendis SOPs, and regulatory guidance is essential, along with working knowledge of clinical management techniques. The role requires strong organizational, communication, and project management skills in a regulated, fast-paced environment.
