[Remote] Clinical Trial Management Associate (CTMA), Oncology (EMEA/LATAM)

Note: The job is a remote job and is open to candidates in USA. Maleda Tech is hiring a Clinical Trial Management Associate (CTMA) to support the execution and oversight of global oncology clinical trials. In this contract role, you will manage study responsibilities, ensure data quality, and collaborate with various teams to facilitate trial operations.

Responsibilities

• You will 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, collaborating closely with assigned global (gCSM) and regional (rCSM) Clinical Study Management teams
• You will manage and coordinate critical study activities with minimal oversight, including site communications and the maintenance of study timelines, risk logs, and action trackers
• You will lead the coordination and execution of assigned site start-up activities across multiple countries, working closely with regulatory, study start-up, and site engagement and monitoring teams
• You will independently maintain and oversee Trial Master File (TMF) quality and completeness in collaboration with TMF Operations, ensuring inspection readiness at all times
• You will draft, review, and manage study documents such as monitoring plans, training materials, and site communications under the guidance of the CTM
• You will track and reconcile investigational product (IP) and clinical supply or lab shipments, proactively flagging discrepancies and partnering with supply chain to resolve issues
• You will support site-level budget tracking, invoice reconciliation, and vendor communications in partnership with Clinical Operations and Finance
• You will coordinate and contribute to key study meetings, including agenda development, facilitation, and action item follow-up, and you will monitor enrollment and site performance metrics to support analysis and mitigation strategies
• You will partner with the data manager lead to ensure timely site follow-up for query reconciliation against study milestones, and you will ensure compliance with study protocols, SOPs, and regulatory guidelines (ICH-GCP, FDA) across all operational activities

Skills

• You hold a bachelor's degree with 3 or more years of relevant clinical trial experience, or a master's degree with 1 to 2 years of experience
• You have a demonstrated ability to work independently and manage multiple competing priorities with minimal oversight, and a strong understanding of clinical trial processes and regulatory requirements (ICH-GCP, FDA)
• You have working experience supporting trials in the LATAM and EMEA regions
• You bring excellent organizational and time management skills with high attention to detail, along with strong written and verbal communication skills and the ability to interact confidently with internal stakeholders and external partners
• This position requires fluency in one of the following languages due to the nature of site interactions across EMEA and LATAM: Portuguese, German, Italian, French, or Polish
• Previous oncology trial experience is strongly preferred
• Experience using clinical systems such as CTMS, EDC, and eTMF is highly valued, and Veeva Vault experience is a plus
• Proficiency in the Microsoft Office Suite (Word, Excel, PowerPoint, Project) will help you ramp quickly

Benefits

• Contract to hire position
• Hybrid (Remote and In Person)
• Minimum 3 days onsite at Millbrae, CA location
• Full-time, 40 hours per week (8 hours/day, 5 days/week)

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