Associate II, TMF Operations – Europe/LATAM

This is a fully remote position, open to applicants in United Kingdom, +8 more countries.

📋 Description

• Evaluate and authorize key TMF documents in accordance with relevant SOPs and operational procedures.

• Manage, assess, and address rejected TMF documents across intricate studies or sponsor portfolios in both electronic and hard-copy formats.

• Conduct regular TMF Quality Control assessments to ensure adherence to regulatory standards, ICH GCP, sponsor requirements, and industry best practices.

• Develop TMF Quality Control checklists for Project Team evaluation and keep related study documentation and trackers up to date.

• Employ electronic document management and eTMF systems to accurately review, classify, and process essential documents.

• Recognize and report TMF trends, issues, and quality concerns to the RMC Lead, escalating matters promptly when necessary.

• Assist the RMC Lead with study SharePoint documentation and other administrative tasks, providing deputy coverage as needed.

• Ensure essential documents are maintained in compliance with relevant SOPs, ALCOA principles, country regulations, and established document management protocols.

• Collaborate with Worldwide Project Team members globally, engaging with RMC Leads and internal teams to identify TMF trends, resolve issues, and uphold high standards throughout the document lifecycle.

⛳️ Requirements

• A university degree is preferred, preferably in Life Sciences, along with 1–2 years of relevant experience.

• Proficiency in English, showcasing strong written and verbal communication abilities.

• Familiarity with an electronic document repository or eTMF, complemented by robust skills in document recognition, data collection, indexing, and editing.

• Basic understanding of clinical research principles and processes; experience in a highly regulated industry is a plus.

• Exceptional attention to detail, with the capacity to manage multiple intricate tasks accurately in a fast-paced, deadline-driven environment.

• Strong planning and organizational capabilities, sound judgment, and the ability to work effectively under general guidance while seeking assistance when necessary.

• Capability to comprehend document cross-checks and dependencies within an eTMF and adhere to standardized document naming conventions.

• Proficiency in Microsoft Word and Excel, with the ability to understand and comply with applicable Worldwide and sponsor standard operating procedures.

🏝️ Benefits

• Comprehensive health insurance coverage.

• Opportunities for professional development and career progression.

• Flexible working arrangements to promote work-life balance.

• Collaborative and innovative work environment.