Senior Clinical Trials Manager, Global Cell Therapy

Artiva Biotherapeutics Inc.; San Diego (CA); Presencial; USD 165.000 - 185.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, and Vision

Group Life Insurance

Long Term Disability (LTD)

401(k) Retirement Plan

Employee Assistance Program (EAP)

Flexible Spending Account (FSA)

Paid Time Off (PTO)

Company holidays, including year-end

Bonus.ly recognition program

Descripción de la vacante

Artiva Biotherapeutics Inc. in San Diego seeks a Sr. Clinical Trials Manager to oversee the operational aspects of one or more clinical studies from protocol development through database lock. The Sr. CTM will be a member of the Artiva Clinical Operations team.

You will manage external vendors and CROs, develop study materials, monitor enrollment, ensure regulatory compliance, and support data management and study reporting to drive timely trial milestones.

Formación

• At least seven years of experience in clinical trial management.
• Experience in Cell Therapy, Autoimmune or Rare Disease preferred.
• Travel approximately 25% of the time, with occasional international travel.
• Management experience in a matrixed environment.
• Demonstrated knowledge of GCP/ICH guidelines and FDA regulations.

Responsabilidades

• Oversee external vendors and CROs to ensure study deliverables.
• Coordinate protocol development, IB updates, and study reports.
• Design study materials such as CRFs, patient diaries, and source documents.
• Assist with protocol development and study report completion.
• Monitor activities with CROs to ensure adherence to GCP/SOPs.
• Provide guidance to CRAs and coordinate data management activities.
• Track patient enrollment and site performance; assist in data review.
• Review study quality metrics and coordinate site document reviews.
• Plan investigator meetings and support regulatory submissions.

Conocimientos

Oral and written communication

MS Office

Educación

BA/BS degree

Nursing degree

Advanced life sciences degree

Descripción del empleo

Artiva Biotherapeutics Inc. in San Diego seeks a Sr. Clinical Trials Manager to oversee the operational aspects of one or more clinical studies from protocol development through database lock. The Sr. CTM will be a member of the Artiva Clinical Operations team.

You will manage external vendors and CROs, develop study materials, monitor enrollment, ensure regulatory compliance, and support data management and study reporting to drive timely trial milestones.