Director, Clinical Data Management Organization

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 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.
• Overseas 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.

• 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.

Preferred Skills:

• Oncology experience, especially in solid tumors.
• 5 or more years’ direct line management experience., Advertising, Auditing, Case Report Form (CRF), Clinical Data, Clinical Data Management, Clinical Practices/Protocols, Clinical Trial, Clinical Trial Management, Clinical Validation, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Data Management, Data Modeling, Data Processing, Database Programming, Delivery Management, Documentation, Drug Development, Electronic Data Capture (EDC), FDA Requirements, Follow Through, GCP (Good Clinical Practices), ICH Regulations, Identify Issues, Management Strategy, Medical Coding, Medical Products, Medical Terminology, Medical Treatment, Mentoring, Oncology, Outsourcing, Presentation/Verbal Skills, Problem Solving Skills, Project Estimates, Project/Program Management, Purchasing/Procurement, Quality Control, Quality Metrics, Reconciliation, Relationship Management, Requirements Management, Research & Development (R&D), Sales Management, Short Messaging Service (SMS), Standard Operating Procedures (SOP), Statistics, Team Player, Test Plan/Schedule, Time Management, Vendor/Supplier Management, Writing Skills

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that 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.