Associate II, TMF Operations - Europe - Remote

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are a global team of over 3,500+ experts, bright thinkers, dreamers and doers, and together, we are changing the way the world experiences CROs.

About Us

Our mission is to work with passion and purpose every day to improve lives, and we are looking for others who value this same pursuit. We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

About the Department

At Worldwide, TMF Operations handles the processing, maintenance, and archiving of all essential documents in strict accordance with pertinent Standard Operating Procedures, country-specific regulations, and industry best practices. Our culture of collaboration and innovation propels us in our pursuit of excellence in clinical research and making a meaningful impact on every patient's life. Roles within our TMF Operations department have a global scope, with the opportunity to regularly collaborate with members of the Worldwide Project Team.

Responsibilities

• Fulfill the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operating 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 electronic and hard copy formats.
• Prepare periodic TMF Quality Control checklists for review by the Project Team.
• 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

• Possess data collection, indexing, and editing skills, including the 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 the use of an electronic document repository or eTMF.
• General understanding of clinical research principles and processes.

Qualifications

• University Degree preferred (Life Science desirable).
• Up to 2-3 years of relevant TMF experience within the CRO/Pharma industry.