Job Overview
Location
5 Locations
Job Type
Full-time
Category
Operations
Date Posted
June 3, 2026
Full Job Description
đź“‹ Description
- • Manage a portfolio of complex clinical studies or sponsor-specific TMF (Trial Master File) operations with global scope, ensuring full compliance with regulatory standards and internal SOPs.
- • Serve as the primary point of contact for Project Teams and Sponsors, providing Subject Matter Expertise (SME) on TMF requirements, documentation standards, and regulatory expectations.
- • Oversee the Quality Control process for TMF documentation, including planning audits, identifying non-compliance issues, and implementing corrective and preventive actions.
- • Develop and maintain project-specific TMF Quality Management Documents to align with sponsor and regulatory expectations.
- • Prepare, analyze, and present TMF Key Performance Indicators (KPIs) and data trends to internal teams and external sponsors to drive continuous improvement and compliance.
- • Support and coordinate regulatory inspections and sponsor audits, leading the resolution of audit findings related to TMF documentation and recordkeeping.
- • Collaborate cross-functionally with global project teams to ensure timely, accurate, and complete TMF assembly and maintenance across multiple therapeutic areas and geographies.
- • Apply in-depth knowledge of clinical research regulations (e.g., ICH-GCP, FDA, EMA) to guide TMF structure, content, and retention practices.
- • Identify gaps in TMF processes and propose scalable, compliant solutions to enhance efficiency and reduce risk across studies.
- • Maintain clear, concise, and professional written and verbal communication with internal stakeholders and external sponsors to ensure alignment on TMF expectations and deliverables.
- • Work in a fast-paced, deadline-driven environment while managing multiple priorities without compromising quality or regulatory compliance.
- • Contribute to the continuous improvement of TMF operations by participating in process optimization initiatives and knowledge sharing within the Records Management Compliance department.
🎯 Requirements
- • Proficient understanding of clinical research principles, industry standards, and regulations applicable to TMF Management
- • Demonstrated ability to plan, organize, and execute tasks under pressure in a fast-paced, deadline-oriented environment
- • Strong interpersonal and communication skills for clear and concise interaction with internal teams and external sponsors
- • University degree preferred (Life Science desirable) with 2–4 years of relevant experience in a CRO or pharmaceutical industry setting
- • Knowledge of working within a highly regulated industry, specifically in clinical trial documentation or records management
- • Experience supporting regulatory or sponsor audits and resolving audit findings related to TMF compliance
🏖️ Benefits
- • Opportunity to work remotely across Europe with global team collaboration
- • Role in a mission-driven organization focused on improving patient lives through innovative clinical research
- • Supportive, inclusive, and diverse workplace culture that encourages creativity and professional growth
- • Exposure to complex, high-impact clinical trials with global sponsors and regulatory agencies
Skills & Technologies
About Worldwide Holdings Corporation
Worldwide Holdings Corporation is a diversified global enterprise engaged in the development, manufacturing, and marketing of a wide range of products and services. The company operates across various sectors, including technology, consumer goods, and industrial solutions, with a strong focus on innovation and sustainability. Worldwide Holdings Corporation is committed to delivering high-quality products and exceptional customer service, aiming to foster long-term relationships with its clients and stakeholders. The company's strategic vision involves expanding its global reach, investing in research and development, and adapting to evolving market demands to maintain a competitive edge in the international marketplace. Their mission is to create value through responsible business practices and a dedication to excellence.
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