Sr. Clinical Trial Manager
Budget / Salary$165,000–185,000
TypeFull-time job
LocationUnited States
Posted2 hours ago
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 .
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.
In addition to a great culture, we offer:
· 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.
If all this speaks to you, come join us on our journey!
Base Salary: $165,000 - $185,000. Exact compensation may vary based on level, skills and experience.
Originally posted on Himalayas
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 .
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.
In addition to a great culture, we offer:
· 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.
If all this speaks to you, come join us on our journey!
Base Salary: $165,000 - $185,000. Exact compensation may vary based on level, skills and experience.
Originally posted on Himalayas
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