Senior Manager, Clinical Data Management

It’s all good news! At Relay Therapeutics, our portfolio continues to evolve, and projects continue to move rapidly into clinical development creating greater complexity of collaboration, information sharing, and need for coordination. As Sr Manager, Clinical Data Management you will be an integral member of the team and play an instrumental role in delivery, integrity, and quality of Relay Tx’s clinical data analyses across the clinical studies. You will report to the Director, Clinical Data Management. Your roleYou will be responsible for oversight and execution of data management activities for assigned clinical studies including data timelines and key deliverablesYou will work directly with and oversee CROs and vendors for outsourced Data Management activities and be responsible for CRO performance and data management metrics for assigned studiesYou will lead database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines and related operations manualsYou will lead data validation specifications for assuring the accuracy of clinical trial data, e.g., manual data review guidelines, computerized edit check programs, Data Management Plans (DMP).You will be responsible for executing or overseeing data cleaning activities through to database lock: includes generating and managing clinical trial data queries, data review listings, coding specified clinical trial data, e.g. adverse events and concomitant medications, reconciling serious adverse events and central labs.You will function as support to the lead data manager for a clinical study and provide technical and business expertise in support of data management activitiesYou will lead and collaborate with study team members on data cleaning activities and provide oversight of CRO data cleaning activities and database lock activitiesYou will review, maintain and perform completeness QCs of study eTMF for Data Management documentationYou will oversee and participate in RAVE user access QCsYou will collaborate with a dynamic Relay cross-functional team to ensure timeliness and quality of data deliverablesYou will participate and/or represent Data Management at study team meetings, as neededYou will ensure compliance with global regulatory requirements and quality standardsMust be familiar with industry standard data cleaning toolsProvide technical and business expertise in support of data management deliverablesYour backgroundYou should ideally have 7+ years of experience in the pharmaceutical/biotechnology and/or CRO industry as a Data Manager (sponsor experience is preferred)Data cleaning experience in Oncology studies is preferredYou have experience in Medidata RaveYou have advanced experience with data collection and cleaning covering Phase I/II/III studies and Healthy Volunteer studiesYou have experience in CRO and vendor oversightYou are a motivated self-starter who is capable of flourishing in a fast-paced small company environmentYou have experience in integration of external vendor systems with EDC (Rave)Advanced skills in excel are requiredYou are a creative problem-solver with excellent communication and public speaking skillsYou have strong interpersonal and organizational skills, with a high degree of attention to detailYou are pragmatic and able to manage multiple projects and priorities effectivelyEstimated Salary Range: [$129,000 - $184,000]The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location.#BP1About Relay TherapeuticsRelay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!