Associate I, TMF Operations - Europe/Latam - Remote

📋 Description

• • Join Worldwide Clinical Trials, a global, midsize Contract Research Organization (CRO) renowned for its boundary-pushing innovation and commitment to advancing cures for the world's most persistent diseases. We are not a company that plays it safe; we are built by pioneers who take creative approaches and implement them with unwavering quality and excellence.
• • As part of our global team of over 3,500 experts, bright thinkers, dreamers, and doers, you will contribute to changing the way the world experiences CROs, making a tangible difference in patient lives.
• • Our mission is to work with passion and purpose every day to improve lives, and we are seeking individuals who share this fundamental pursuit.
• • The Records Management Compliance (RMC) Department, specifically the TMF Operations team, plays a critical role in ensuring the integrity and compliance of all essential documents throughout the clinical research process.
• • This team is responsible for the meticulous processing, maintenance, and archiving of all essential documents, adhering strictly to pertinent Standard Operating Procedures (SOPs), country-specific regulations, and industry best practices.
• • At Worldwide Clinical Trials, our culture of collaboration and innovation is the driving force behind our pursuit of excellence in clinical research and our commitment to making a meaningful impact on every patient's life.
• • Roles within TMF Operations have a global scope, offering the unique opportunity to collaborate regularly with members of the Worldwide Project Team, fostering a dynamic and interconnected work environment.
• • In this Associate I, TMF Operations role, you will be entrusted with fulfilling the crucial "TMF Approver" function as defined by the relevant SOPs and working practices, ensuring the highest standards of document management.
• • Your primary responsibility will involve the diligent processing, thorough review, and effective resolution of rejected Trial Master File (TMF) documents. This will encompass managing documents for multiple studies, handling both electronic and hard copy formats with precision.
• • You will gain hands-on experience working with a variety of Electronic Document Management Systems (EDMS) and electronic TMF (eTMF) systems, where you will classify and process Essential Documents, contributing directly to the accuracy and completeness of study records.
• • A key aspect of your role will be direct communication with the RMC Lead, providing timely reports on trends and issues relevant to the TMF, enabling proactive problem-solving and continuous improvement.
• • You will be empowered to escalate any TMF Quality issues promptly to the RMC Lead, ensuring that potential risks are identified and addressed swiftly to maintain regulatory compliance.
• • This position also involves providing essential administrative support to the RMC Lead. This includes, but is not limited to, meticulous filing and maintaining internal documents on study SharePoint sites, such as TMF Quality Control checklists and various tracking documents, ensuring organized and accessible project information.
• • You will be expected to perform additional tasks as assigned by your Line Manager, demonstrating flexibility and a willingness to contribute to the broader team objectives.
• • This role is ideal for an individual with strong data collection, indexing, and editing skills, who possesses a keen ability to adhere to standardized document naming conventions and meticulous record-keeping.
• • Excellent written and verbal communication skills are essential, enabling you to clearly and concisely present information and collaborate effectively with internal teams.
• • You will be expected to execute tasks under general direction, demonstrating initiative while also knowing when to seek assistance as needed, fostering a proactive and supportive work dynamic.
• • The role requires sound judgment and the ability to identify decisions that require supervisory approval, ensuring compliance and risk mitigation.
• • Proficiency in Microsoft Word and Excel is a prerequisite for this role, providing the foundational tools for document management and data handling.
• • You will develop proficiency in the use of an electronic document repository or eTMF system, alongside honing your document recognition skills, which are vital for efficient TMF management.
• • A general understanding of clinical research principles and processes is beneficial, providing context for the importance of TMF operations.
• • This is an excellent opportunity to grow within a highly regulated industry, contributing to life-changing clinical trials while working in a supportive and innovative global environment.