Clinical Trial Manager

Location
92121, San Diego
Posted
Sep 28, 2021
Hotbed
NextGen Bio
Required Education
Bachelors Degree
Position Type
Full time

Key Responsibilities:

  • Assist with third-party vendor training on protocols and practices. Coordinate the logistics of Artiva product readiness with sites and internally within Artiva. Work cross-functionally with product manufacturing, QA and supply chain management, to coordinate site training, product delivery, supply management to ensure readiness and product availability prior to patient treatment.
  • Developing and maintaining good working relationships with CRO, investigators and study staff.
  • Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
  • Ensure timely response to queries and monitoring discrepancies.
  • Manage the investigational product (IP) and non-IP study accountability and reconciliation process.
  • Oversee the performance of CROs and third-party vendors, including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Clinical Operations Managers.
  • Perform clinical data review of data listings and summary tables, including query generation.
  • Perform initial review of CRO and other third-party study vendor invoices for correctness.
  • Plan and conduct investigator meetings as directed.
  • Review key study quality metrics (e.g. patient eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
  • Review and/or approve IP release packages.
  • Tracking and report on current progress of the study including site activation, patient enrollment, monitoring visits and data submission backlogs.
  • Contribute to the preparation of clinical protocols, amendments, informed consent forms, study manuals and guides, electronic case report forms, and any other clinical research related documents.
  • Participate in the planning of quality assurance activities, coordinating the resolution of applicable audit findings.
  • Ensure audit-ready condition of clinical trial documentation including central clinical files; review monitoring visit reports to ensure quality and resolution of site-related issues; coordinates and assist in the planning of regulatory or ethics committee activities, as appropriate.
  • Collaborate with cross-functional teams (e.g. Medical Monitor, Regulatory Affairs, CRO, vendors and Investigators/site staff).
  • Prepare and/or review study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Pharmacy Manual, CRF Completion Guidelines, etc.).
  • Prepare/review site study documents (i.e., site-specific informed consent, study tools/worksheets, investigator contracts, and site payments).
  • Manage clinical monitoring activities (including approval of visit report templates, monitoring plan, etc.) ensuring compliance with ICH/GCP and applicable regulations, including the management through resolution (e.g. CAPA) of any site or study level issues, deviations, etc.
  • Participate in the selection, training, and evaluation of study personnel (contract and internal) to ensure the efficient operation of the function.

Qualifications:

  • Undergraduate degree in life sciences, graduate degree preferred.
  • Therapeutic experience in cell therapy and oncology strongly preferred.
  • Five or more years’ experience managing clinical trials as the sponsor; prior working experience at a CRO is a plus.
  • Thorough knowledge of clinical research concepts, practices, FDA regulations and ICH guidelines regarding drug development and data management methods.
  • Experience monitoring sites and conducting other site management activities.
  • Proven experience in early phase clinical trials.
  • Strong site management and CRO management skills required.
  • Proven communicator, both oral and written.

Artiva Biotherapeutics is an equal employment opportunity employer.