Clinical Trial Management Associate, Oncology (EMEA/LATAM) at Eikon Therapeutics

Millbrae, CA; Jersey City, NJFull-timeClinical OperationsPosted about 2 months ago

About the Role

<div class="content-intro">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.</div>Position As a Clinical Trial Management Associate (CTMA), you will serve as a critical inhouse clinical operations partner in the execution, and oversight of Phase I–III global oncology clinical trials. Positioned between the Clinical Trial Associate (CTA) and Clinical Trial Manager (CTM), the CTMA brings increased ownership, autonomy, and judgment to the execution of clinical studies. You will independently manage assigned study responsibilities and help ensure the delivery of high-quality, compliant, and timely trial data in support of our mission to bring transformative therapies to patients. This role requires a minimum of 3 days per week onsite (or more, as business needs require) in either our Jersey City (NJ), or Millbrae (CA) offices. This position requires fluency in one of the following languages due to the nature of site interactions in various regions in EMEA or LATAM: Portuguese, German, Italian, French, Polish.    About You You bring a strong operational mindset, an ability to work independently, and a flexible and collaborative spirit. You are looking to grow beyond a CTA role and take on more direct responsibility for study deliverables, bringing with you valuable clinical research experience and a strong passion to contribute meaningfully to drug development through consistent operational excellence. What You’ll Do <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Manage and coordinate critical study activities with minimal oversight such as site communications, and maintenance of study timelines, risk logs, and action trackers.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Independently maintain and oversee trial master file (TMF) quality and completeness, in collaboration with TMF Operations, ensuring inspection readiness at all times.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Draft, review, and manage study documents such as monitoring plans, training materials, and site communications under the guidance of the CTM.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Track and reconcile investigational product (IP) and clinical supply/lab shipments, proactively flagging discrepancies and collaborating with supply chain to resolve issues.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Support site level budget tracking invoice reconciliation, and vendor communications in partnership with Clinical Operations and Finance.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Monitor enrollment and site performance metrics, contributing to analysis and mitigation strategies to meet enrollment goals and drive operational excellence. </li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">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.).</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Ensure compliance with study protocols, SOPs, and regulatory guidelines (e.g., ICH-GCP, FDA) across all operational activities.</li> </ul> Qualifications <ul> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Bachelor’s degree with 3+ years of relevant clinical trial experience or a Master’s degree with 1–2 years of experience.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Demonstrated ability to work independently and manage multiple competing priorities with minimal oversight.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Strong understanding of clinical trial processes and regulatory requirements (ICH-GCP, FDA).</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Experience using clinical systems such as CTMS, EDC, and eTMF; Veeva Vault experience is a plus.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Excellent organizational and time management skills with high attention to detail.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Strong written and verbal communication skills and ability to interact confidently with internal stakeholders and external partners.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project).</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Previous oncology trial experience preferred but not required.</li> <li style="font-size: 12pt; font-family: arial, helvetica, sans-serif;">Working experience in LATAM/EMEA</li> </ul> At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">401k plan with company matching</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Mental health and wellness benefits</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Weeklong summer and winter holiday shutdowns</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Generous paid time off and holiday policies</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies </li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Enhanced parental leave benefit</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Daily subsidized lunch program when on-site</li> </ul> The expected salary range for this role is $122,000 to $133,000 depending on skills, competency, and the market demand for your expertise.<div class="content-conclusion">Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. 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.</div>

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