Associate Director, Clinical Data Management at Revolution Medicines

Redwood City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

27 Apr, 26

Salary

233000.0

Posted On

27 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Data Management, Leadership, Collaboration, Data Management Strategy, Quality Control, ICH Regulations, FDA Regulations, GCP Guidelines, Medical Coding, Data Standardization, Project Management, Communication, Multi-tasking, Problem Solving, Oncology Trials, Database Development

Industry

Hospitals and Health Care

Description

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit 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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. 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. This person will 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. 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 Skills, Experience and Education: MS, BS/BA with 12+ years of related experience or other suitable qualification with relevance to the field. Direct 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. Preferred Skills: Experience working within the biotechnology or pharmaceutical industry. Deep experience supporting oncology clinical trials, including hands‑on involvement with the operational and data‑related complexities unique to oncology studies. #LI-Hybrid #LI-DN1 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. Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. Base Pay Salary Range $186,000—$233,000 USD

Responsibilities

The Associate Director will manage day-to-day Clinical Data Management activities and collaborate with functional leaders to ensure clinical trial success. This includes overseeing data management tasks, managing external vendors, and providing comprehensive status updates to project teams.