Director, Clinical Data Management

About the role

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. The Director, Clinical Data Management will represent Revolution Medicines (RevMed) CDM in Clinical Team meetings and collaborate closely with other functional leaders to ensure clinical trial success.

Responsibilities

• Define project-level data management strategy.
• Identify requirements for capturing and processing clinical data ensuring accuracy, consistency, and completeness.
• 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, and query management to identify and resolve errors and inconsistencies in clinical data.
• Provide CDM oversight of outsourced and partner-resourced clinical trials, including scoping trials, project management, relationship management, approval of deliverables, and coordination of internal reviewers.
• Plan, coordinate, and manage CDM tasks for clinical studies.
• Participate in and review CRO proposals.
• Act as primary liaison with CROs, third-party data vendors, and EDC vendors.
• Review clinical protocols and cross-functional plans.
• Serve as primary reviewer or author of case report forms (CRFs) and CRF completion guidelines.
• Oversee and participate in all aspects of EDC database development, testing, maintenance, and lock/unlock.
• Ensure Data Management Plans are followed throughout the course of studies.
• Set and manage Data Management project timelines.
• Provide 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.
• Implement data standardization and maintain 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.

Requirements

• MS, BS/BA degree, or other suitable qualification with relevance to the field.
• 15 or more years’ direct experience 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.
• Experience from the industry is essential.

Preferred Skills

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

Pay

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $211,000 - $264,000 USD. The range will be adjusted for the local market a candidate is based in. Individual base pay salary is determined by multiple factors, including job-related skills, experience, and market dynamics.

Benefits

Base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.