About Artiva:

Artiva Biotherapeutics is a cell therapy company with a “Manufacturing-First” strategy. We developed our manufacturing platform to advance highly scaled, off-the-shelf, allogeneic natural killer (NK) cell therapies for outpatient administration in the treatment of cancer and autoimmune diseases. Our pipeline comprises both highly active non-genetically modified NK cell and CAR-NK cell therapies. Our non-genetically modified NK cells can be used as antibody-dependent cellular cytotoxicity (ADCC) enhancers in patients undergoing monoclonal antibody therapy. Our genetically modified CAR-NK cell therapies leverage the innate biology and safety features of NK cells, while enhancing their efficacy with chimeric antigen receptors (CARs). Artiva solves many of the previous challenges in cell therapy to deliver potentially life-saving treatments with safe, effective, scalable, versatile, and cost-effective NK cell products. Artiva is headquartered in San Diego.

Job Summary:

Artiva Biotherapeutics is seeking an experienced Senior Clinical Data Manger who will report to the Associate Director of Clinical Data Management, or higher. This role will be responsible for Data Management activities from study start-up to close-out. This person will work closely with key functional areas and external vendors to lead and oversee clinical data management activities and ensure the timely and successful delivery of high-quality data. Functional areas include, but are not limited to Clinical Operations, Clinical Development, Statistics, Translational Sciences, Program Management, Regulatory, Finance and Legal.

Duties/Responsibilities:

• Review and approve Data Management documents
• Coordinate and lead Artiva Unit Acceptance Testing (UAT) activities
• Participate in development of project level timelines
• Coordinate and lead Artiva data quality reviews
• Review and provide feedback to clinical team on other study documents e.g., Statistical Analysis Plan, Monitoring Plan
• Participate in regular study and project team meetings
• Provide oversight of Data Management activities performed by Clinical Research Organization (CRO) to include, but not limited to:
• • • Electronic Data Capture (EDC) system development and modifications
    • Development of Data Management documents e.g., Case Report Forms, Data Management Plan, build and validation specifications
    • Development and management of Data Management timelines
    • Serious Adverse Event (SAE) and third-party data reconciliations
    • Development of third-party Data Transfer Agreements (DTAs)
    • CRO quality Data Management deliverables e.g., Metrics, extracts, reports
    • Database soft and hard lock activities

Requirements:

• Minimum 5-8 years of pharmaceutical, biotech or CRO industry experience
• Track record of managing and overseeing Data Management activities directly or through CRO and third-party service providers
• Extensive knowledge of data management documents e.g., CRFs, DMP, specifications
• Understanding of applicable regulatory guidelines and industry standards e.g., ICH GCP and FDA guidelines, 21 CFR 11
• Extensive knowledge of EDC systems e.g., Medidata Rave, Medrio
• Knowledge of cell therapy in oncology or autoimmune therapeutic areas preferred
• Bachelor’s degree in science, computer science, or related field preferred
• Working knowledge of Microsoft tools e.g., SharePoint, Word, Excel
• Strong written, verbal, and interpersonal communication skills

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 cancer patients. We are tenacious – laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients. 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:

· A beautiful facility 

· 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!

Artiva Biotherapeutics is an equal employment opportunity employer.

Base Salary: $126,000 - 164,000 . Exact compensation may vary based on skills and experience.