Global Clinical Trials Manager, Cell Therapy & Autoimmune

Artiva Biotherapeutics, Inc.; San Diego (CA); On-site; USD 165,000 - 185,000; Full time

Benefits offered by this job

Medical, Dental, and Vision insurance

Group Life Insurance

Long Term Disability (LTD)

401(k) Retirement Plan

Employee Assistance Program (EAP)

Flexible Spending Account (FSA)

Paid Time Off (PTO)

Year-end holidays and company holidays

Bonus.ly rewards program

Job summary

Artiva Biotherapeutics, Inc. is seeking a Sr. Clinical Trials Manager to oversee operational aspects of one or more clinical studies from protocol development through database lock.

You will be a key member of the Artiva Clinical Operations team, driving vendor management, study material design, and regulatory adherence. You will coordinate CROs, monitor trial progress, ensure GCP/ICH/FDA compliance, and guide CRAs while maintaining study master files and communicating with cross-functional

Qualifications

• BA/BS or nursing degree, or advanced life sciences; degree in life sciences preferred.
• At least seven years of experience in clinical trial management.
• Experience in Cell Therapy, Autoimmune or Rare Disease preferred.
• Management of people in a matrixed environment.
• Management of global clinical trials.
• GCP, ICH guidelines and FDA regulations knowledge.
• Ability to work independently and in a team.
• Travel of ~25%, with occasional international travel.

Responsibilities

• Oversee external vendors and CROs.
• Prepare study documents per ICH GCP and Artiva SOPs.
• Design study materials (CRFs, diaries, source documents).
• Assist with protocol development and study reports.
• Manage monitoring via CROs or on-site, ensure GCP compliance.
• Guide CRAs directly or via CRO.
• Track enrollment and coordinate data management tasks.
• Review study quality metrics and take action with study team.
• Coordinate IP release packages and study supplies.
• Negotiate contracts with vendors and support finance reconciliation.
• Review informed consent forms and CRFs.
• Plan and participate in investigator meetings.
• Support data query process.
• Assure regulatory compliance at sites.
• Maintain trial master file.

Skills

Excellent oral and written comms

Strong organizational abilities

Ability to work independently and in a

Travel 25%

Education

BA/BS or nursing degree or advanced life sciences

Tools

MS Office

Job description

Artiva Biotherapeutics, Inc. is seeking a Sr. Clinical Trials Manager to oversee operational aspects of one or more clinical studies from protocol development through database lock.

You will be a key member of the Artiva Clinical Operations team, driving vendor management, study material design, and regulatory adherence. You will coordinate CROs, monitor trial progress, ensure GCP/ICH/FDA compliance, and guide CRAs while maintaining study master files and communicating with cross-functional