Full-Time

Clinical Data Manager

Revolution Medicines

Revolution Medicines

201-500 employees

Develops targeted therapies for RAS-addicted cancers.

Biotechnology

Compensation Overview

$120,000 - $158,000Annually

+ Equity + Learning and Development Opportunities

Mid, Senior

San Carlos, CA, USA

Required Skills
Management
Word/Pages/Docs
PowerPoint/Keynote/Slides
Requirements
  • Bachelor's degree in health sciences, Life Sciences, or health-related field preferred.
  • At least five years for 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.
  • CRO/service provider experience desired.
  • Knowledge of industry standards (CDISC, SDTM, CDASH) desired.
  • Prior oncology/solid tumor experience highly desirable.
  • 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.
Responsibilities
  • 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 provides 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.

REVOLUTION Medicines stands out in the oncology field for its unique approach to drug discovery, leveraging insights from nature and evolution to develop targeted therapies for RAS-addicted cancers. The company's robust drug discovery and medicinal chemistry capabilities have resulted in a deep pipeline of RAS inhibitors, with their most advanced product, RMC-4630, currently in a multi-cohort Phase 1/2 clinical program. This focus on genetic drivers and adaptive resistance mechanisms in cancer, coupled with their commitment to exploring mechanism-based dosing paradigms and in-pathway combinations, positions REVOLUTION Medicines as a leader in precision oncology.

Company Stage

IPO

Total Funding

$1.3B

Headquarters

Redwood City, California

Founded

2014

Growth & Insights
Headcount

6 month growth

20%

1 year growth

58%

2 year growth

97%