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TMF Manager

Company: EQRx
Location: Cambridge
Posted on: January 12, 2022

Job Description:

TEAM: Clinical Operations
Who We AreWe're a new kind of biotech, one with a bold mission to bring innovative new medicines at dramatically lower costs.
What You'll DoYou will ensure the required documents that reside in the trial master file (TMF) (as per the Study-Specific Master Plan and Master List) are always inspection ready. You will work with study team to define the TMF Plan and to build the Study Master list from the Toolkit - TMF Master List. You will support manual TMF filing and mapping to electronic TMF system. You will define the expected documents for the study and maintain appropriate placeholder or Expected Document Lists in the eTMF system in collaboration with the study team (the study team serves as SME for their respective departments). You will work proactively and prospectively with TMF Contributors at Study, Country and Site level to ensure timely uploading of all Essential Documents in the TMF. You will periodically perform risk-based quality reviews of the TMF content by utilizing metrics and reports to assess any missing documents and then following-up with the appropriate functional group or document owner to mitigate, as per the established review schedule.
You will resolve noncompliance with overdue quality review findings and overdue "In-Progress" eTMF documents, which will improve the accuracy of the TMF. You will monitor and identify TMF trends and escalate concerns to management. You will generate, organize, and deliver on TMF performance metrics at the site, study, country, and compound levels and at study completion, ensure the TMF is ready to be archived. You will coordinate the long-term storage archival of original documents and maintain document integrity per retention policies. You will manage complex export requests for Health Authorities and divestitures and independently solve technical issues and leverage interpersonal and influencing skills to foster partnerships across multidisciplinary teams. You will assist in overall change management and build collaborative relationships with cross-functional team and third-party vendors.
You will participate in reviewing and updating documents to ensure that they are reflective of industry standards, applicable regulations and are easily retrieved following a regulatory inspection. You will exhibit strong project management skills that include working closely with the study teams to achieve goals and meet success criteria within specified timelines. You will provide support to TMF implementation, internal audits, and regulatory inspections.
The Impact You Will HaveThis is not your standard TMF Manager position. This role is a highly visible position and of significant impact to the company. We are on a critical mission to bring quality solutions to patients at a fraction of the price. This role will help us drive forward towards that pinnacle goal of truly putting patients first.
Who You Are

  • You have a bachelor's degree in related field such as science, nursing, or other biomedical disciplines.
  • You have experience in clinical research and/or Trial Master Files.
  • You have experience working in an eTMF.
  • You have a minimum 5 years document management experience.
  • You are highly organized and collaborative.
  • You are an excellent communicator.
  • You are very proficient with tools like Excel, PowerPoint, and MS Word.
  • You can make decisions, deliver on commitments, share knowledge, acknowledge other's achievements, and collaborate with peers to meet objectives or timelines in a rapidly changing environment.
  • You can participate and work effectively on multiple cross-functional teams
  • You understand relationships are key and have strong interpersonal skills.
  • You can thrive in a smaller company environment and love the pace of a true startup.
  • You are a team player who is willing to roll-up your sleeves and get the job done.
    Are you bold enough? Your work should matter and allow you the freedom to be 100% you. We spend too much time and effort in our career to not feel excited and proud about what we do and who we do it with. In other words, your career is too important for your next move to be just another job, so let's work together to change the world and bring affordable medicines to all patients.We aren't about a bunch of empty slogans on a wall or words on a coffee cup - you can find that in lots of places. We are a culture of individuals with diverse backgrounds and personalities.
    What does EQRx stand for?--- EQuality Medicines: Equally good or better, innovative medicines--- EQuitable Medicines: Making innovative medicines affordable--- EQual Access: Sustainable, frictionless access for people to cutting-edge medicines
    We have a bold mission and are looking for equally bold people who want to join us and help make a difference in the world. If you want to grease the wheel, we are definitely not for you. Want to build the wheel? We might be just what you are looking for.
    Subject to legally required accommodations, candidates should be aware that EQRx currently maintains a policy requiring all employees to be fully vaccinated against COVID-19.
    EQRx is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Keywords: EQRx, Cambridge , TMF Manager, Executive , Cambridge, Massachusetts

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