Clinical Trial Management Associate, Oncology (EMEA/LATAM)
Eikon Therapeutics · Jersey City, NJ · 3 wk ago
Information Technology$122k–$133k/yrFull-time
About the role
Eikon Therapeutics is a biopharmaceutical company focused on discovering novel treatments for life-threatening diseases using advanced technologies. The Clinical Trial Management Associate (CTMA) will support the execution and oversight of global oncology clinical trials.
Responsibilities
- Proactively support the Clinical Study Management team in the day-to-day execution of global clinical trials.
- Manage and coordinate critical study activities with minimal oversight, including site communications, maintaining study timelines, risk logs, and action trackers.
- Lead the coordination and execution of site start-up activities across multiple countries, collaborating with regulatory, study start-up, and site engagement and monitoring teams.
- Maintain and oversee trial master file (TMF) quality and completeness, ensuring inspection readiness.
- Draft, review, and manage study documents such as monitoring plans, training materials, and site communications.
- 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.
- Coordinate and contribute to key study 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.
- Partner with data manager lead to ensure timely site follow-up for query reconciliation to meet study milestones.
- Ensure compliance with study protocols, SOPs, and regulatory guidelines (ICH-GCP, FDA).
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, or 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
- 401(k) plan with company matching
- Medical, dental, and vision insurance (premiums covered by Eikon)
- 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)
- 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.