Senior Manager, Site Engagement And Monitoring Excellence (contract)
Eikon Therapeutics
Jersey City, NJ, USA
On-site
Oversee clinical site engagement and monitoring
Develop and maintain strong site relationships
Onboard and train cras
Establish and foster effective relationships with internal and external stakeholders, such as the CRO and study team members
Job Summary
Establish and foster effective relationships with internal and external stakeholders, such as the CRO and study team members.
Onboard and train CRAs to conduct high quality site qualification, initiation, and monitoring visits.
Contribute to monitoring process improvement initiatives by developing functional area Standard Operating Procedures (SOPs), Work Instructions (WIs), job aids, and tools.
Matching Summary
Establish and foster effective relationships with internal and external stakeholders, such as the CRO and study team members.
Skills & Requirements
Must-have
Oversee clinical site engagement and monitoring
Develop and maintain strong site relationships
Onboard and train CRAs
Review and approve monitoring trip reports
Perform monitoring oversight activities
Utilize CTMS and TMF
Nice-to-have
Passion for leading, training, and mentoring CRAs
Creative and independent issue resolution
Contribute to process improvement initiatives
Key Requirements
8+ years of experience with a Bachelor's degree, or 6+ years with a post graduate degree
Experience utilizing Veeva CTMS and TMF is required
Experience supporting site and/or sponsor inspections is required