Trial Master File Specialist

As one of the largest Clinical Research Organizations in the world, operating four ultramodern Clinical Research Units globally, the jewel in the crown is our facility in the UK (Leeds.) A brand new, world class, state-of-the-art 65,000 ft² clinic with 100 beds (and growing), fully dedicated to Phase I Clinical research. And this is where you come in because the laboratory in the Clinic is expanding and is now seeking our next Document Specialist 1.

• This is a remote, full-time and permanent job in the UK.

Who You Are You bring any experience within an administrative role within clinical trials, or a hospital, medical setting, physician or GP office. Experience working with computers and basic programs, especially Adobe Acrobat, Word, Excel, Outlook and PowerPoint. It´s Ideal If You Bring Any Experience Working With Trial Master File (eTMF), But Full Training Will Be Provided. The Important Thing For Us Is You Are Familiar With An Environment That Is

• Fast paced: where no deviations from regulations are allowed, as they will create a quality issue.
• Changing priorities constantly asking you to prioritize and adapt on the spot.
• Teamwork and people skills are essential for the study to run smoothly
• Attention to detail focused where accuracy in data review is vital to be successful
• Technology based. We collect our data directly into an electronic environment.

ON A NORMAL DAY, YOU WILL… You will work in International Phase 1 clinical trials. All our teams in the UK live to answer one question: is the drug safe? Under this framework, you will:

• Work directly with your team of Project Manager & Project Coordinator to review and finalize the Trial Master File Plan (TMF) and Index for clinical trials.
• Maintain the TMF by working with applicable project team members to retrieve, file, and upload documents in accordance with applicable SOPs, policies, system, and client requirements.
• Document QC, to ensure documents are correct and accurate.
• Create and/or maintain document/file-related tracking forms and/or spreadsheets.
• Perform archiving duties for all paper and/or electronic media, as needed.
• Maintain departmental files including, but not limited to, project files.

Embark on a fulfilling career as you support us on our mission “To help make life-changing healthcare solutions possible”. Apply now and be part of an extraordinary journey. Learn more about our EEO & Accommodations request here.