Eikontherapeutics

Clinical Trial Management Associate, Oncology (EMEA/LATAM)

Millbrae, CA; Jersey City, NJ

Sponsorship not specified$122k-$147kDetected 2 days ago

GCPExcelSupply ChainClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationCollaborationTime ManagementMicrosoft Office

About the role

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.
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.
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.

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.
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.
Support site level budget tracking invoice reconciliation, and vendor communications in partnership with Clinical Operations and Finance.
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.).

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.
Strong understanding of clinical trial processes and regulatory requirements (ICH-GCP, FDA).
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project).
Demonstrated ability to work independently and manage multiple competing priorities with minimal oversight.
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.
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%)

Additional language proficiency in: Portuguese, Spanish, French, German, Italian is a plus.
Experience using clinical systems such as CTMS, EDC, and eTMF
Veeva Vault experience is a plus.
Previous oncology trial experience preferred but not required.

At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:

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.

This listing is sourced directly from Eikontherapeutics's careers page and normalized into a canonical job model.