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Senior Manager, Site Engagement and Monitoring Excellence
4 months ago
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
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 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.
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 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.Qualifications
Minimum education: Completion of a bachelor’s degree (scientific or clinical field is preferred) is required. An advanced degree is preferred. 8+ years of experience with a Bachelor's degree, or 6+ years with a post graduate 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. 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.At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
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-siteThe expected salary range for this role is $157,000 to $171,000 depending on skills, competency, and the market demand for your expertise.
Eikon 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. For purposes of this section, Fully Vaccinated means (i) the completion of the vaccination regimen as approved by the FDA (by way of example, 2 doses of the Pfizer or Moderna vaccine and 1 dose of the Johnson and Johnson vaccine), and (ii) timely receiving booster vaccination, as recommended by the Centers for Disease Control and Prevention.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
