Senior Manager, Clinical Data Management

Relay Therapeutics; Cambridge (MA); On-site; USD 129,000 - 184,000; Full time

Job summary

Relay Therapeutics seeks a Sr Manager, Clinical Data Management to oversee data management activities across clinical studies, ensuring data quality, integrity, and timely delivery. You will lead CRO oversight, database development, eCRF design, and data cleaning through to database lock in a fast-paced, collaborative setting.

Your background includes 7+ years in pharma/biotech/CRO as a Data Manager, with preference for Oncology and experience in Medidata Rave, EDC integrations, and advanced

Qualifications

• 7+ years of experience in the pharmaceutical/biotechnology and/or CRO industry as a Data Manager.
• Data cleaning experience in Oncology studies is preferred.
• Sponsor experience is preferred.
• Experience with Medidata Rave and EDC integration with external vendor systems.

Responsibilities

• Oversee and execute data management activities for assigned studies, including timelines and key deliverables.
• Oversee CROs and vendors for outsourced data management activities and monitor performance and metrics.
• Lead database development, eCRF design, UAT, data import specs, CRF completion guidelines, data entry guidelines and related manuals.
• Lead data validation specifications to ensure trial data accuracy (edit checks, DMPs).
• Execute or oversee data cleaning through to database lock, including queries, listings, coding and reconciliation of SAEs and central labs.
• Provide technical and business expertise to support data management activities and study teams.
• Collaborate with study team members and oversee CRO data cleaning and database lock activities.
• Review and maintain completeness QCs of study eTMF for Data Management documentation.
• Oversee RAVE user access QCs and ensure compliance with regulatory standards.

Skills

Data management expertise

Project coordination

Communication & public speaking

Interpersonal skills

Tools

Medidata Rave

EDC integration

MS Excel advanced

Job description

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 role

• You will be responsible for oversight and execution of data management activities for assigned clinical studies including data timelines and key deliverables
• You 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 studies
• You will lead database development and eCRF design, UAT, data import specifications, Case Report Form completion guidelines, data entry guidelines and related operations manuals
• You 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 activities
• You will lead and collaborate with study team members on data cleaning activities and provide oversight of CRO data cleaning activities and database lock activities
• You will review, maintain and perform completeness QCs of study eTMF for Data Management documentation
• You will oversee and participate in RAVE user access QCs
• You will collaborate with a dynamic Relay cross-functional team to ensure timeliness and quality of data deliverables
• You will participate and/or represent Data Management at study team meetings, as needed
• You will ensure compliance with global regulatory requirements and quality standards
• Must be familiar with industry standard data cleaning tools
• Provide technical and business expertise in support of data management deliverables

Your background

• You 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 preferred
• You have experience in Medidata Rave
• You have advanced experience with data collection and cleaning covering Phase I/II/III studies and Healthy Volunteer studies
• You have experience in CRO and vendor oversight
• You are a motivated self-starter who is capable of flourishing in a fast-paced small company environment
• You have experience in integration of external vendor systems with EDC (Rave)
• Advanced skills in excel are required
• You are a creative problem-solver with excellent communication and public speaking skills
• You have strong interpersonal and organizational skills, with a high degree of attention to detail
• You are pragmatic and able to manage multiple projects and priorities effectively

Estimated Salary Range: [$129,000 - $184,000]

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About Relay Therapeutics

Relay 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!