[Hiring] Senior Clinical Trial Manager @Artiva Biotherapeutics

Role Description

The Sr. Clinical Trials Manager (Sr. CTM) is responsible for oversight and execution of the operational aspects of one or more clinical studies from protocol development through database lock. The Senior Clinical Trials Manager (Sr. CTM) will be a member of the Artiva Clinical Operations team.

• Manage external vendors and contract research organizations
• Prepare study documents as required to conduct the trial per ICH GCP and per evolving Artiva SOPs
• Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards, and source documents
• Assist with protocol development, Investigator Brochure (IB) update, and study report completion
• Manage monitoring activities via contractors or via CRO, including on-site clinical monitoring or co-monitoring with a CRA at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols
• Provide guidance, direction, and management to CRAs directly or via CRO
• Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; assist in coordination of data management activities
• Review key study quality metrics (e.g. patient eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team
• Coordinate study supplies and review/approve IP release packages as required
• Negotiate contracts with vendors of clinical trial services, maintain monthly invoice awareness, and support management and finance in reconciliation tasks
• Review Informed Consent Forms, CRFs, and study-related materials
• Plan and participate in investigator meetings
• Assist and support data query process
• Assure regulatory compliance of investigation sites with Artiva’s SOPs and FDA and ICH guidelines
• Ensure trial master file is current and maintained

Qualifications

• 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 is 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
• Demonstrated ability to work independently and in a team environment
• Travel of approximately 25% required, with occasional international travel
• Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
• Excellent oral and written communication skills and strong organizational abilities

Benefits

• An entrepreneurial, highly collaborative, and innovative environment
• Comprehensive benefits, including:
• 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
• Our recognition program, Bonus.ly, is where you can trade in points earned for things you want

Company Description

Artiva is a clinical-stage, publicly-traded biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK®, is an allogeneic, off-the-shelf, non-genetically modified NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is delivered in the outpatient setting with no required hospitalization.

Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia, and New Zealand) to GC Cell’s NK cell manufacturing technology and programs. Artiva is headquartered in San Diego, California.