Posted on: January 12, 2022
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
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
- 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
- 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
- You can participate and work effectively on multiple
- You understand relationships are key and have strong
- 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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