Senior Manager, Site Engagement and Monitoring Excellence (Contract)

Position 

We are seeking a highly experienced, collaborative, and detail-oriented Contract Senior Manager capable of helping Eikon optimize its clinical Site Engagement and Monitoring function to support 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.

This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our California or New Jersey offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.

About You

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.

What You’ll Do 

• 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