Sr. Clinical Trial Manager

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

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 environment
• Travel of approximately 25% of travel 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

Why you should apply:

We have a fantastic team and philosophy! We are passionate – We deeply care about our team, our science, and improving the lives of autoimmune and cancer patients. We are tenacious – we are laser-focused on our mission and undeterred in our commitment to make cell therapies broadly accessible to patients with autoimmune disease and cancer. We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive – committed to the diversity of our team and ensuring that all voices are heard.

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.

Base Salary: $165,000 - $185,000. Exact compensation may vary based on level, skills and experience.