Clinical Trial Management Associate, Oncology (EMEA/LATAM)
Eikon Therapeutics · Millbrae, CA · 3 wk ago
Analyst$122k–$133k/yrFull-time
About the role
The Clinical Trial Management Associate (CTMA) serves as a critical in-house clinical operations partner in the execution and oversight of Phase I–III global oncology clinical trials. 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.
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.
- Cook up 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.
Requirements
- Bachelor’s degree with 3+ years of relevant clinical trial experience or a Master’s degree with 1–2 years of experience.
- Working experience in LATAM/EMEA is a must-have.
- Additional language proficiency in: Portuguese, Spanish, French, German, Italian is a plus.
- 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).
Qualifications
- Previous oncology trial experience preferred but not required.
Benefits
- 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
Pay
The expected salary range for this role is $122,000 to $133,000 depending on skills, competency, and the market demand for your expertise.
Schedule
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.