Revolution Medicines

Senior Clinical Data Manager

Redwood City, California, United States · Senior · Full-time

Sponsorship not specified$164k-$205kDetected 22 hours ago

GCPComplianceExcelICD-10Clinical TrialsFDA RegulatorySASCommunicationMicrosoft Office

About the role

The Senior 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.
This person may have project level oversight of junior data managers and/or Clinical Data Associates (CDAs).
The core duties and responsibilities of the Sr/CDM are delineated below.

Reviews protocols for appropriate data capture including electronic Case Report Form (eCRF) design and external data vendors' systems.
Provides DM support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.

CDM of Data Management experience in the pharmaceutical or biotechnology industry, depth and exposure to DM related tasks considered in lieu of minimum requirement.
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.
Proven ability to work both independently and in a team setting.

Bachelor's degree in health sciences, Life Sciences, Mathematics, Computer Sciences, or health-related field.
Requires solid knowledge of clinical data management principles, clinical trials 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).
Ability to handle multiple projects and prioritize effectively, well organized and detail oriented.
CRO/Service provider management experience.
Prior oncology/solid tumor experience highly desired.
Working knowledge of statistical programming packages (e.g. SAS) is a plus.

$164,000 - $205,000 USD
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process.

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.

This listing is sourced directly from Revolution Medicines's careers page and normalized into a canonical job model.