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Director, Clinical Data Management

Company: Revolution Medicines, Inc.
Location: Redwood City
Posted on: June 12, 2021

Job Description:

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit high-value 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 scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

This position is a key role in the day-to-day management of Clinical Data Management (CDM) activities. Including timely and professional management of clinical trial data for all relevant phases. Represents Revolution Medicines (RevMed) CDM in Clinical Team meetings. This person will be required to collaborate closely with other functional leaders to ensure clinical trial success. Defines project-level data management strategy. Identifies requirements for capturing and processing of clinical data ensuring accuracy, consistency and completeness. Manages external vendors providing clinical data. Manages and/or performs data management tasks according to strict quality standards including SAE reconciliation, third party vendor data reconciliation, medical coding processing, protocol deviation collection, query management to identify errors and inconsistencies in clinical data and ensure their resolution. Provides CDM oversight of outsourced and partner-resourced clinical trials including scoping trials, project management, relationship management, approval of deliverables, and coordination of internal reviewers.

In this position, you will be responsible for RevMed's Clinical Data Management functions, specifically:

  • Plans, coordinates, and manages CDM tasks for clinical studies.

  • Participate and review CRO proposals.

  • Acts as primary liaison with CROs, third party data vendors, EDC vendors.

  • Reviews clinical protocols and cross functional plans.

  • Serves as primary reviewer or author of case report forms (CRFs) and CRF completion guidelines.

  • Oversees and participates in all aspects of EDC database development, testing, maintenance, and lock/unlock.

  • Ensures Data Management Plans are followed through the course of the studies.

  • Sets and manages Data Management project timelines.

  • Provides comprehensive status updates to project team members.

  • Address data issues identified by cross-functional team members, accountable for external data vendor documentation, management, and reconciliation.

  • Assist in defining and creating data listings, summary table validation, data specifications and process data transfers in preparation for statistical review and data management audit

  • Implements data standardization and maintains data model across projects.

  • Direct management and mentoring responsibilities for internal data management team members.

  • Lead department initiatives e.g. development of SOPs.

  • Other duties as assigned.

Required Experience, Skills, and Education:

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

  • Hands-on experience of designing and running early-stage clinical trials.

  • Knowledge of, and experience with databases, standards, medical terminology, medical coding dictionaries, quality control processes and auditing procedures.

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

  • 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.

  • Excellent written and verbal communication skills.

  • Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important.

  • Industry experience is essential.

Keywords: Revolution Medicines, Inc., Redwood City , Director, Clinical Data Management, Other , Redwood City, California

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