Senior Manager, Clinical Site Engagement and Monitoring Excellence

3 days ago

Hayward, California, United States Eikon Therapeutics Full time
About the Role

Eikon Therapeutics is a pioneering biopharmaceutical company at the forefront of revolutionary technology, combining chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Our discovery platform is built on groundbreaking innovations from our founders, culminating in the creation of microscopes that enable real-time, molecular-resolution measurements of protein movement in living cells, unlocking previously intractable classes of proteins as drug targets.

Key Responsibilities
  • Establish and foster effective relationships with internal and external stakeholders, including the CRO and study team members.
  • Promote awareness of Eikon's clinical pipeline and programs to trial sites, investigators, and networks.
  • Complete or oversee the qualification of sites and promptly facilitate site selection to support study milestone goals.
  • Develop and maintain strong site relationships to support the site/patient experience and drive study team goals such as enrollment and major study milestones.
  • Onboard and train CRAs to conduct high-quality site qualification, initiation, and monitoring visits.
  • Review and approve monitoring trip reports in the Clinical Trial Management System (CTMS).
  • Perform and document monitoring oversight activities to assess monitoring quality and CRA performance.
  • At times, perform the CRA role as needed, to support prompt site qualification, initiation, monitoring, and close-out visits at key sites to meet urgent study milestones.
  • Regularly review site and monitoring Key Risk Indicator (KRI) metrics to detect issues and ensure prompt resolution.
  • Serve as an escalation point for CRAs and as a Subject Matter Expert (SME) to resolve site management and monitoring quality issues and develop/ensure implementation of Corrective and Preventive Action (CAPA) Plans as needed.
  • Support CRAs to ensure sites are inspection-ready and support Eikon Clinical Quality Assurance during site inspections.
  • Effectively utilize the CTMS and Trial Master File (TMF) to ensure SEME documents are promptly filed and site data is accurate.
  • Contribute to monitoring process improvement initiatives by developing functional area Standard Operating Procedures (SOPs), Work Instructions (WIs), job aids, and tools.
  • Contribute to improving site selection, monitoring, and monitoring oversight trip report templates in Veeva CTMS by identifying gaps, suggesting updates, testing, and implementing change controls.
Requirements
  • 8+ years of experience with a Bachelor's degree, or 6+ years with a postgraduate degree.
  • 2+ years of clinical trial line management experience is required (CRA line management experience is preferred).
  • Experience utilizing Veeva CTMS and TMF is required.
  • Experience supporting site and/or sponsor inspections is required.
  • Site travel of approximately 50% is required; this travel percentage could occasionally increase to meet urgent business needs.
  • Working on-site from an Eikon office location (New York, NY; Jersey City, NJ, or Hayward, CA) 3 days per week is required during non-travel weeks.
About Eikon Therapeutics

Eikon Therapeutics is proud to be an equal opportunity employer and will consider all qualified applicants for employment. In accordance with the Company's duty to provide and maintain a safe workplace, the Company requires all employees to be Fully Vaccinated with one of the FDA-approved COVID-19 vaccines, which includes those vaccines that have received the FDA's emergency use authorization. You will be expected to be Fully Vaccinated as of your Start Date. If you believe that you are exempt from this requirement under an applicable law or regulations, including Americans with Disabilities Act and California's Fair Employment and Housing Act, you will need to contact the Company's Human Resources group.

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