Associate II, TMF Operations

🔥 10 minutes ago

🌐 Spain, Poland, +3 more countries – Remote

🇪🇸 Spain – Remote 🇵🇱 Poland – Remote 🇬🇪 Georgia – Remote 🇬🇧 United Kingdom – Remote 🇷🇸 Serbia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

⚙️ Operations

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

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

• Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices. • Process, review, and resolve rejected Trial Master File (TMF) documents, for complex studies or Sponsor portfolio of studies both in an electronic and hard copy format. • Prepare periodic TMF Quality Control checklists for review by Project Team review. • Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices. • Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents

🎯 Requirements

• Up to 2-3 years of relevant TMF experience within the CRO/Pharma industry • University Degree preferred (Life Science desirable) • Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions • Possess excellent written and verbal communication skills to clearly and concisely present information • Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment • Handle multiple, highly detailed tasks with exceptional accuracy. • Demonstrate strong planning and organizational skills • Demonstrate proficiency in Microsoft Word and Excel • Develop proficiency in use of an electronic document repository or eTMF. • General understanding of clinical research principles and processes

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options