Sr. Clinical Trial Manager

About Artiva:

Artiva is 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.

AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases (Rheumatoid Arthritis,  Systemic Sclerosis, Idiopathic Inflammatory Myopathies and Sjögren’s  Disease), as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers.

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.

For more information, visit  www.artivabio.com .

Job Summary:

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.

Duties/Responsibilities:

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, (may occasionally include 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; and 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

Ensures 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 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 en