Senior Associate I, TMF Operations

🕒 August 21

🌐 Argentina, Mexico, +1 more countries – Remote

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⏰ Full Time

🟠 Senior

⚙️ Operations

👻 Ghost score 18%

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Logo of Worldwide Clinical Trials

Worldwide Clinical Trials

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Perform RMC Lead Activities, managing complex studies or a Sponsor portfolio of studies • Communicate with Project Team members and Sponsors to assess TMF-related project needs and provide Subject Matter Expertise • Oversee Quality Control processes, including planning, reporting and follow-up on non-compliance • Assist in developing project-specific TMF Quality Management Documents • Prepare, maintain and present TMF Key Performance Indicators and underlying data analysis trends • Support Regulatory and Sponsor audits and audit finding resolution when necessary

🎯 Requirements

• Proficient understanding of clinical research principles, industry standards and regulations applicable to TMF Management • Strong planning and organizational skills with ability to work under pressure • Strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment • Excellent written and verbal communication skills • Ability to identify solutions and make decisions or consult to find optimal regulatory compliant solutions, including for complex technical situations • University degree preferred (Life Science desirable) • A combination of education plus 1-3 years of relevant experience • Knowledge of working within a highly regulated industry or experience of CRO/Pharmaceutical Company industry

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