Senior Clinical Trial Manager
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Job Description
Senior Clinical Trial Manager overseeing global clinical studies for Artiva, a biotechnology company developing NK-cell therapies. Managing vendors, sites, monitoring, compliance, and trial operations through database lock.
Responsibilities:
- Oversee and execute operational aspects of one or more clinical studies from protocol development through database lock
- Manage external vendors and contract research organizations
- Prepare study documents according to ICH GCP and Artiva SOPs
- Coordinate and oversee design of study materials, including CRFs, patient diaries, study participation cards, and source documents
- Assist with protocol development, Investigator Brochure updates, and study report completion
- Manage monitoring activities through contractors or CROs, including occasional on-site clinical monitoring or co-monitoring with a CRA
- Provide guidance, direction, and management to CRAs directly or through CROs
- Track patient enrollment; qualify, initiate, monitor, close out, and review clinical study sites
- Assist with coordination of data management activities and data queries
- Review study quality metrics and determine appropriate actions with the study team
- Coordinate study supplies and review/approve investigational product release packages
- Negotiate clinical trial service vendor contracts and support invoice reconciliation
- Review informed consent forms, CRFs, and study-related materials
- Plan and participate in investigator meetings
- Assure regulatory compliance with Artiva SOPs, FDA regulations, and ICH guidelines
- Ensure the trial master file is current and maintained
Requirements:
- BA/BS, nursing degree, or advanced degree; degree in the life sciences preferred
- At least seven years of experience in clinical trial management
- Experience in Cell Therapy, Autoimmune or Rare Disease strongly preferred
- Past management of people in a matrixed environment
- Management of global clinical trials
- Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations
- Ability to work independently and in a team environment
- Approximately 25% travel required, with occasional international travel
- Proficiency with MS Office, including Word, Excel, PowerPoint, and Outlook
- Excellent oral and written communication skills
- Strong organizational abilities
Benefits:
- 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 paid holidays, including the year-end holiday week
- Bonus.ly recognition program, where points can be traded for desired items
- Entrepreneurial, highly collaborative, and innovative environment
- Passionate, tenacious, innovative, transparent, and inclusive company culture
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