Director, Clinical Data Management

Revolution Medicines•Redwood City, CA

2d•Hybrid

About The Position

Revolution Medicines is a global, commercial-stage oncology company dedicated to discovering, developing, and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide. Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency, and hold ourselves to a high standard of rigor—all in service of patients. The Opportunity: This position has 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. The Director, Clinical Data Management, 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. Manage 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, and 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. Plans, coordinates, and manages CDM tasks for clinical studies. Participates and reviews CRO proposals. Acts as primary liaison with CROs, third-party data vendors, and 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. Addresses data issues identified by cross-functional team members, accountable for external data vendor documentation, management, and reconciliation. Assists 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. Leads department initiatives, e.g., development of SOPs. Other duties as assigned.

Requirements

MS, BS/BA degree, or other suitable qualification with relevance to the field.
15 or more years’ direct experience of designing and running early-stage or late-stage clinical trials.
Knowledge of, and experience with, clinical 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.
Experience from industry is essential.

Nice To Haves

Oncology experience, especially in solid tumors.
5 or more years’ direct line management experience.

Responsibilities

Manage external vendors providing clinical data.
Manage and/or perform 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.
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.