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Clinical Study Risk Manager

Company: EQRx
Location: Somerville
Posted on: January 16, 2022

Job Description:

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.Who We Are:We're a new kind of biotech, one with a bold mission to bring innovative new medicines at dramatically lower costs.What You'll Do: You will coordinate cross-functional risk management for assigned assets/clinical trials in accordance with ICH GCP E6 requirements. You will provide subject matter expertise for the training, development, and maintenance of the study level risk assessment and will support the study team in drafting and finalizing the initial risk assessment, ensuring cross functional involvement.You will drive the risk assessment process for assigned studies and run risk assessment initial meetings and subsequent review meetings. You'll partner with study teams(s) to identify and analyze areas of risk and facilitate the right decision mitigations. You will work to ensure quality risk discussions by stimulating critical thinking with cross-functional teams and review and approve clinical study risk assessments with EQRx Clinical Project Management. This role will manage risk and mitigation libraries and lead the team to establish, plan, and implement new mitigations for newly identified risks.You will work to ensure the appropriate actions are taken by teams/cross functional leads (CFLs) to investigate, resolve, and document risks. You will facilitate study team(s) in the development of study risk-based quality management plans and provide guidance to team members to better understand the Risk Based Quality Management (RBQM) process and risk assessment. You'll also participate in Study Team meetings and Program Management meetings and review and provide input on protocols and protocol amendments. You will assist in the development of Key Risk Indicators (KRIs)/Key Performance Indicators (KPIs)/Quality Tolerance Limits (QTLs) and review study plans based on the output of the risk assessment. You will also develop modern vision approaches to gain efficiencies, increase quality, and streamline the risk-based quality management process.The Impact You Will HaveThis is not your standard study level risk manager role. 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.Your Professional SuperpowersYou have a bachelor's degree and at least 10 years industry experience.You can perform complex root cause analysis with study / cross functional teams with a proven ability of strong decision making and problem-solving skills.You have a strong knowledge of electronic systems e.g., electronic case report form, electronic Trial File Master, and Clinical Trial Management System.You have experience in risk-based and central monitoring.You constantly monitor industry best practices, changes in global regulations and guidelines, and recommend changes and upgrades to existing policies, standard operating procedures, and systems.You are able to support the development of Risk Management Group, coordination of evaluation of technologies, analyze existing processes and implement effective changes as needed, to reduce costs and improve timelines.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'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?

Keywords: EQRx, Somerville , Clinical Study Risk Manager, Executive , Somerville, Massachusetts

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