Associate II, TMF Operations - EMEA - Fixed term - Remote

Are you a meticulous professional with a passion for precision in clinical trials? Do you thrive in a dynamic environment, ensuring every crucial document is flawlessly managed and compliant? If you're ready to make a significant impact from anywhere in the world, then this remote Associate II, TMF Operations role with Lifelancer might be your next exciting career step! We're seeking a dedicated individual to join our team on a fixed-term basis, focusing on our EMEA operations. This is your chance to contribute to vital research, all while enjoying the flexibility of a fully remote setup.

Overview

At Lifelancer, we believe in the power of well-managed data to transform lives. As an Associate II, TMF Operations, you will play a pivotal role in the systematic organization and maintenance of our Trial Master Files for studies across the EMEA region. This fixed-term, full-time position is entirely remote, offering you the flexibility to contribute your expertise from your home base, anywhere in the world. You'll be instrumental in ensuring our TMFs are inspection-ready, uphold the highest quality standards, and comply with all relevant regulatory guidelines, contributing directly to the integrity and success of our clinical research programs.

Key Responsibilities

In this essential role, you will:

Proactively manage and maintain the Trial Master File for assigned studies, ensuring accuracy, completeness, and adherence to company SOPs and regulatory requirements (ICH-GCP).
Perform ongoing quality control reviews of TMF documents, identifying and resolving any discrepancies or missing information promptly.
Collaborate closely with study teams, CRAs, and other departments to facilitate timely document collection and filing.
Support preparation for audits and regulatory inspections, providing necessary documentation and explanations related to TMF content.
Track TMF progress and metrics, reporting on completion status and flagging potential issues.
Assist in the preparation of study start-up, close-out, and archival activities for TMFs.
Contribute to the development and improvement of TMF-related processes and training materials.

Requirements

A minimum of 1-2 years of experience in TMF management within a CRO or pharmaceutical setting.
Solid understanding of clinical trial processes, regulatory requirements, and ICH-GCP guidelines.
Exceptional organizational skills and meticulous attention to detail.
Proven ability to work independently in a remote environment, managing multiple tasks and deadlines effectively.
Strong verbal and written communication skills in English.
Proficiency with electronic Trial Master File (eTMF) systems.
Experience supporting studies within the EMEA region is highly advantageous.

What You'll Gain

Joining Lifelancer means becoming part of a forward-thinking team committed to improving global health. You'll gain invaluable experience in a specialized area of clinical operations, honing your skills in TMF management within a dynamic, international context. This fully remote, fixed-term opportunity offers not only professional growth but also the chance to contribute meaningfully to groundbreaking research, all while maintaining a flexible work-life balance. You'll collaborate with passionate experts across various countries, expanding your network and making a tangible difference in the lives of patients worldwide.