Eikon Therapeutics - Clinical Trial Management Associate, Oncology (EMEA/LATAM)
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Requirements
• Bachelor’s degree with 3+ years of relevant clinical trial experience or a Master’s degree with 1–2 years of experience. • Demonstrated ability to work independently and manage multiple competing priorities with minimal oversight. • Strong understanding of clinical trial processes and regulatory requirements (ICH-GCP, FDA). • Experience using clinical systems such as CTMS, EDC, and eTMF; Veeva Vault experience is a plus. • Excellent organizational and time management skills with high attention to detail. • Strong written and verbal communication skills and ability to interact confidently with internal stakeholders and external partners. • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project). • Previous oncology trial experience preferred but not required. • Working experience in LATAM/EMEA • 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-site • The expected salary range for this role is $122,000 to $133,000 depending on skills, competency, and the market demand for your expertise.
Responsibilities
• Proactively support Clinical Study Management team members in the day-to-day execution of global clinical trials, with increasing independence and accountability for specific study components. Collaborate closely with assigned global (gCSM)/regional Clinical Study Management (rCSM) teams, ensuring operational excellence throughout study execution. • Manage and coordinate critical study activities with minimal oversight such as site communications, and maintenance of study timelines, risk logs, and action trackers. • Lead the coordination and execution of site start-up assigned activities across multiple countries, working closely with regulatory, study start-up, and site engagement and monitoring excellence inhouse teams. • Independently maintain and oversee trial master file (TMF) quality and completeness, in collaboration with TMF Operations, ensuring inspection readiness at all times. • Draft, review, and manage study documents such as monitoring plans, training materials, and site communications under the guidance of the CTM. • Track and reconcile investigational product (IP) and clinical supply/lab shipments, proactively flagging discrepancies and collaborating with supply chain to resolve issues. • Support site level budget tracking invoice reconciliation, and vendor communications in partnership with Clinical Operations and Finance. • Coordinate and contribute to key study meetings (e.g., team meetings, vendor meetings, investigator meetings), including agenda development, meeting facilitation, and action item follow-up. • Monitor enrollment and site performance metrics, contributing to analysis and mitigation strategies to meet enrollment goals and drive operational excellence. • Partner with data manager lead to ensure timely site follow up (assigned sites) for query reconciliation to meet the study milestones (e.g., interim analyses goals, etc.). • Ensure compliance with study protocols, SOPs, and regulatory guidelines (e.g., ICH-GCP, FDA) across all operational activities.
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 • The expected salary range for this role is $122,000 to $133,000 depending on skills, competency, and the market demand for your expertise.
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