Clinical Trial Management Associate jobs in United States
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Eikon Therapeutics · 18 hours ago

Clinical Trial Management Associate

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology to discover novel treatments for life-threatening diseases. The Clinical Trial Management Associate will serve as a critical in-house clinical operations partner in the execution and oversight of Phase I–III global oncology clinical trials, ensuring high-quality and compliant trial data.

BiotechnologyHealth CareLife ScienceMedical
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H1B Sponsor Likelynote

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

Qualification

Clinical trial processesRegulatory requirementsClinical systems experienceOncology trial experienceMicrosoft Office SuiteMultilingual skillsCommunication skillsOrganizational skillsTime management skills

Required

Bachelor's degree with 5+ years of relevant clinical trial experience (e.g., CTA, study coordinator, or CRA) or a Master's degree with 3+ 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)

Preferred

Previous oncology trial experience preferred but not required
Multilingual skills are a plus

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

Company

Eikon Therapeutics

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Eikon Therapeutics is a biopharmaceutical company that develops live-cell resolution microscopy and engineering for drug discovery.

H1B Sponsorship

Eikon Therapeutics has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (17)
2023 (7)
2022 (3)
2021 (1)

Funding

Current Stage
Late Stage
Total Funding
$1.12B
Key Investors
The Column Group
2025-02-26Series D· $350.7M
2023-06-01Series C· $106M
2022-01-06Series B· $518M

Leadership Team

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Roger Perlmutter
Chairman, President, and CEO
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Michael Klobuchar
Chief Operating Officer
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Company data provided by crunchbase