Senior Clinical Trial Lead — Remote & Global Impact

Ascendis Pharma; United States; A distancia; USD 160.000 - 170.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

401(k) plan with company match

Medical, dental, and vision plans

Disability benefits

Flexible spending accounts

Descripción de la vacante

Ascendis Pharma is seeking a Sr. Clinical Trial Manager to lead global and regional trials from Palo Alto, CA or remotely. The role collaborates across cross-functional teams to drive trials to completion on time and with high quality.

The Sr CTM will manage sites, investigators, monitoring activities, eTMF, CTMS, and vendor relations, ensuring regulatory and GCP compliance while supporting auditors and sub-teams. Extensive travel may be required.

Formación

• Bachelor’s degree or master’s degree in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent) preferred, or equivalent work experience.
• Demonstrates mastery knowledge of ICH-GCP, relevant Ascendis SOPs and Work Instructions and regulatory guidance, as well as the ability to implement
• Working knowledge of clinical management techniques and tools
• Direct work experience in a cross-functional environment
• 7+ years of combined experience in managing/monitoring Phase 1, 2, or 3 clinical trials.

Responsabilidades

• Foster and maintain favorable clinical site and investigator relationships.
• Support investigator meetings planning and execution as applicable.
• Review and/or approve IP release packages.
• Monitor compliance to study protocols, regulations and ICH/GCP; track monitoring metrics.

Conocimientos

Clinical trial management

Vendor management

CTMS / eTMF / IRT

GCP Compliance

Communication

Travel readiness

Educación

Bachelor’s or Master’s in life sciences

Herramientas

Veeva Vault eTMF

Veeva EDC

CTMS

Microsoft Office

Descripción del empleo

Ascendis Pharma is seeking a Sr. Clinical Trial Manager to lead global and regional trials from Palo Alto, CA or remotely. The role collaborates across cross-functional teams to drive trials to completion on time and with high quality.

The Sr CTM will manage sites, investigators, monitoring activities, eTMF, CTMS, and vendor relations, ensuring regulatory and GCP compliance while supporting auditors and sub-teams. Extensive travel may be required.