Senior Manager, Site Engagement and Monitoring Excellence

$157,000 - $171,000/Yr

Eikon Therapeutics - Hayward, CA

Full-time - Senior

Hayward, CA

Professional, Scientific, and Technical Services

About the position

We are seeking a highly experienced, collaborative, and detail-oriented senior manager capable of helping Eikon optimize its clinical Site Engagement and Monitoring function to support the delivery of world-class clinical drug development. The successful candidate will work closely with the Eikon Site Engagement and Monitoring Excellence (SEME) team, global Clinical Research Associates (CRAs), and internal study teams across therapeutic areas to oversee clinical site engagement and monitoring activities. You have significant monitoring experience and a passion for leading, training, and mentoring CRAs. You are adept at developing and maintaining relationships with clinical trial sites and demonstrate the ability to oversee monitoring with a strong knowledge of Good Clinical Practice and clinical trial regulations to ensure subject safety, data integrity, and inspection readiness. You have experience developing systems, resources, and tools to support high-quality monitoring and forecast CRA resourcing. You also have experience utilizing a Functional Service Provider (FSP) monitoring model embedded within a sponsor study team to execute major data collection and study milestones. You are a strong collaborator across clinical functional areas with a demonstrated ability to creatively and independently resolve complex issues that impact sites and CRAs.

Responsibilities

• Establish and foster effective relationships with internal and external stakeholders, such as 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 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.

Benefits

• 401k plan with company matching.
• Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%).
• Mental health and wellness benefits.
• Weeklong summer and winter holiday shutdowns.
• Generous paid time off and holiday policies.
• Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies.
• Enhanced parental leave benefit.
• Daily subsidized lunch program when on-site.