Associate Principal Clinical Data Manager at Revolution Medicines

**Who this is for** A seasoned clinical data management professional ready to take project-level oversight and guide data strategy for a high-impact clinical on

Work type: hybrid

Location: Redwood City, California, United States

Salary: $164,000 – $205,000/yr

Type: Full-time

Summary

**Who this is for** A seasoned clinical data management professional ready to take project-level oversight and guide data strategy for a high-impact clinical oncology pipeline. **Key highlights** This role encompasses the full data management lifecycle, from protocol review and eCRF design to database lock, while managing CRO relationships and mentoring junior staff. **You might be a good fit if you...** - Have a broad, fundamental understanding of data management processes in clinical development. - Are experienced in coordinating CRO activities, managing system migrations, and performing User Acceptance Testing (UAT). - Can proactively identify and mitigate study risks while maintaining rigorous data quality standards. - Possess strong leadership skills to mentor junior data managers and facilitate effective cross-functional team communication.

Job Description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Associate Principal Clinical Data Manager is responsible for all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), routine data review through database lock of clinical trials. The Associate Principal CDM has a broad, fundamental knowledge of the data management process and can plan, manage, and coordinate all Data Management activities for assigned study(ies) with minimal guidance. This person may have project level oversight of junior data managers and/or Clinical Data Associates (CDAs).

Specifically, you will be responsible for:

• Represents data management in study team meetings, able to facilitate and provide data management updates and/or input when appropriate.

• Manages data management timelines to coordinate and synchronize deliverables with the overall study timelines.

• Generates and/or reviews/approves study documents (e.g., Data Management Plans, Case Report Forms, DB build specifications, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions, laboratory data handling plan, study protocols).

• Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors’ systems.

• Provides oversight of database set-up/migrations/updates including coordinating and performing UAT.

• Leads the development of internal Data Review Plan and coordinates cross functional team data listing review.

• Coordinates the internal medical coding review.

• Performs ad hoc and scheduled data listing review and generates/resolves queries in EDC.

• Performs external data reconciliation against EDC.

• Performs Serious AE reconciliation according to SOPs and guidelines, as applicable.

• Executes and/or distributes data management metrics, listings, and reports.

• Provides oversight of data management CRO/service providers including manages and monitors the progress of data management activities with CROs and/or other service providers on assigned studies; build effective relationships with CRO/service provider counterparts.

• Reviews and provides feedback to the clinical team on other study documents e.g., Clinical Monitoring plans and vendor specifications.

• Provides training on the EDC system and/or CRF completion guidelines and EDC system to internal or external study team members, as needed.

• Proactively identifies potential study issues/risks and recommends/implements solutions.

• Maintains study DM related documents/files for inspection readiness.

• Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.

• Assists with the training of new employees and/or contractors (e.g., clinical data associates and/or junior clinical data managers working on the studies).

• Participates in CRO/vendor selection process for outsourced activities.

• Supports budget and resource planning across assigned projects.

• Participates in the development, review and implementation of departmental SOPs, templates, and processes.

• Participates in department or cross-functional initiatives (as needed).

• Contributes to a professional working environment through exemplifying RevMed Core Values.

• BS/BA degree or other suitable qualification with relevance to the field.

• 10+ years Data Management experience in the pharmaceutical or biotechnology industry, depth and exposure to DM related tasks considered in lieu of minimum requirement.

• Direct clinical data management experience for early or late-phase clinical trials, understanding process and regulatory requirements.

• Good working knowledge of ICH, FDA, and GCP regulations and guidelines.

• Strong well-rounded technical skills (EDC systems, MS Word, Excel, PowerPoint).

• Knowledge of industry standards (CDISC, SDTM, CDASH).

• Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.

• Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment.

• Ability to handle multiple projects and prioritize effectively, well organized and detail oriented.

• Proven ability to work both independently and in a team setting.

• Early or late-stage oncology clinical trials.

• Solid tumor experience highly desirable.

• A demonstrable record of strong leadership and teamwork.

• Thrives in a collaborative team setting and is driven by a desire to deploy innovative approaches and technologies in a high energy environment.

• Working knowledge of statistical programming packages (e.g., SAS) is a plus.

• CRO/service provider management experience.

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

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