Sr. Clinical Trial Manager

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