Clinical Medical Monitor
EQRx believes responsibility can be revolutionary. Want to make a difference while advancing your career? Come join a team that is working towards our bold mission of developing innovative medicines at radically low prices to help people get the medicines they need.
What You'll Do
You will design protocol strategy and assist with development of regulatory and study documents. You will design a clinical study to meet the agreed strategic context and lead the study team in writing the synopsis and background section of the protocol. You will finalize protocols and amendments and approve the study template informed consent form (ICF). You will coordinate with the study team to review and approve study processes and deliverables and participate in development of Case Report Forms (CRF), statistical analysis plan (SAP) and Data Monitoring Committee (DMC). You will be responsible for study conduct in conjunction with clinical operations.
You will participate in study management team meetings, Data Monitoring Committee (DMC) and steering committees as required. This person will answer safety questions and review the literature as needed, provide input to safety issues and answer questions posed by Institutional Review Board (IRB), Ethics Committee (EC), Data Monitoring Committee (DMC), etc. You will interact with investigative sites and respond to protocol/medical questions. You will provide communication(s) to sites across the study and assist sites with subject evaluation and protocol adherence. You will review safety reports to support regulatory notifications and filings and participate in vendor selection for IRB, DMC and other outsourcing activities.
You will study Level Data Review and perform a review of data generated by data listings or statistical analyses. You will review individual data with Serious Adverse Events (SAEs) and potentially clinically important laboratory test or vital sign abnormalities. You will participate in all reviews and procedures required for database lock and review all patient narratives. You will review outstanding medical or GCP issues report and address issues across the study and provide Study team with medical expertise during key activities. You will answer medical and inclusion/exclusion questions, perform issue resolution, audit responses, and study closeout/inspection readiness. You will oversee and conduct protocol training; produce relevant and materials and deliver protocol training during Investigator meeting and Site Initiation Visit (SIVs). You will lead safety issue workups and review study and individual subject safety for assigned studies and present findings at quarterly drug safety reviews. You will review patient profiles, review study and individual subject safety for assigned studies and present findings at quarterly drug safety reviews. You will contribute to IB updates for the project and assist in the development of scientific meeting abstracts and presentations as well as manuscripts. You will provide input on clinical development plans, protocol design, and risk assessments. You will be coordinating with other personnel on the study to ensure that information is consistent.
The Impact You Will Have
This is not your standard Clinical Medical Monitor position. We are doing things different here than how it is normally done, and this role is no exception. This position is highly visible 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 an MD or MD/PhD
- You have 5 to 10 years of experience in clinical research, with excellent knowledge of the drug development process including but not limited to designing clinical trials, reviewing, and analyzing clinical data, IND, NDA/BLA submissions.
- You have strong knowledge of FDA and ICH regulations regarding clinical research and Good Clinical Practice (GCP)
- You have experience applying scientific knowledge and insight to clinical development strategy and clinical study protocol.
- You have experience with policy, guidance, and procedure development and maintenance.
- You have global experience and have driven new system adoption.
- You demonstrate the ability to analyze existing processes and implement effective changes as needed.
- You have Oncology and immuno-inflammatory experience.
- You can coordinate the ongoing evaluation of products technologies, services, and processes.
- You can identify opportunities to reduce costs and improve timelines.
- You are constantly reviewing publications and information sources to keep updated on current regulations, practices, procedures and proposals.
- You monitor industry best practices, changes in global regulations and guidelines and recommend changes and upgrades to existing policies, SOPs and systems.
- You have a working knowledge of GCP/ICH guidelines and in-depth knowledge of clinical research processes, regulation and methodology.
- You can participate and work effectively on multiple cross-functional teams.
- You play well in the sandbox. You understand relationships are key and have strong interpersonal skills.
- You are a leader. Teams love working with you and you are someone who takes pride in mentoring and supporting the careers of others.
- You can thrive in a smaller company environment and love the pace of a true startup.
- You’re 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?
Are you ready to think differently and embrace the journey?
It’s (mutually) beneficial.
You’re curious about what sets us apart from the rest. What do you get from working at EQRx?
So, let’s start big—working at EQRx means having the opportunity to change the world.
By joining a team that’s remaking medicine development from start to finish, you’re going to enjoy the daily rush of throwing caution to the wind and doing things differently by:
- Working with the smartest game-changers in the industry
- Cutting down the red tape of “the way things are done”
- Seeing and feeling the daily impact of your work
- Growing as a professional and a person
- Committing to neverending social responsibility
And, yes—we also have a killer list of things that’ll help you shine as part of the team.
But to us, these are just table stakes.
- 100% Medical, Dental, and Vision coverage
- Flexible Spending Account
- Health Reimbursement Account
- Free snacks and drinks
*As EQRx grows, please note that some of these are subject to change.
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50 Hampshire StreetTwo-hour street parking is available. There are also several parking garages in the surrounding area.
Cambridge, MA 02139