Clinical Data Manager

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding quality professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

Opportunity: 

The Clinical Data Manager (CDM) actively participates in all aspects of the data management process from the development of project documentation, system set-up, User Acceptance Testing (UAT), and routine data review through database lock of clinical trials.  The CDM has a broad, fundamental knowledge of the data management process and can plan, manage, and coordinate activities for assigned tasks with minimal guidance. This person may have project level oversight as a study Lead Data Manager.  The core duties and responsibilities of the CDM are delineated below.

Specifically, you will be responsible for: 

• Manages data management duties to meet study timelines.

• Review and may distribute/coordinate data management metrics, listings, and reports.

• Performs scheduled and ad hoc 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.

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

• 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.

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

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

• May oversee 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.

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

• May participate in CRO/vendor selection process for outsourced activities.

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

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

Required Skills, Experience and Education:

• Bachelor’s degree.

• At least three (3) years of CDM of Data Management experience in the pharmaceutical, biotechnology, or CRO industry; depth and exposure to DM related tasks considered in lieu of minimum requirement.

• 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).

• 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 project tasks and prioritize effectively.

• Well organized and detail oriented.

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

Preferred Skills: 

• Bachelor's degree in health sciences, Life Sciences, or health-related field.

• CRO/service provider experience desired.

• Prior oncology/solid tumor experience.

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

The base salary range for this full-time position is $116,000 to $145,000 for candidates working onsite at our headquarters in Redwood