Director, Clinical Data Management
Company: Revolution Medicines, Inc.
Location: Redwood City
Posted on: June 12, 2021
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.
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
Participate and review CRO proposals.
Acts as primary liaison with CROs, third party data vendors, EDC
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
Sets and manages Data Management project timelines.
Provides comprehensive status updates to project team
Address data issues identified by cross-functional team members,
accountable for external data vendor documentation, management, and
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
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
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
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
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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