Head of Clinical Data Management

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 03/01/2021
  • Website: revolutionmedicines.com
  • Company Address: 700 Saginaw Drive, Redwood City, CA, 94063

About Revolution Medicines

REVOLUTION Medicines discovers and develops new drugs that harness the therapeutic potential of frontier oncology targets on behalf of cancer patients. Our innovative product engine draws inspiration from nature and evolution, which offer insights into cancer targets, disease mechanisms and therapeutic approaches. We pay particular attention to natural products that are inherently rich with biological function as a result of natural selection and can inform and guide our discovery and development of small molecules that can modulate these targets.

Job Description

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.

The Opportunity:

Position requires innate leadership and organizational skills, and experience with exploratory-stage clinical trials, to provide proper oversight for all aspects of the Revolution Medicines (RevMed) Clinical Data Management function. This position will be responsible for building and leading this function, planning resourcing around forecasted deliverables, identifying technology needs, and pinpointing gaps in systems and processes. This person will be required to collaborate closely with other functional leaders to design best response to business needs.

In this position, you will be responsible for RevMed’s Clinical Data Management functions, specifically:

  • Lead clinical data management oversight of outsourced RevMed clinical trials including project management, vendor management, coordination of internal reviews, and approval of deliverables. Oversee database design and production, ensuring that CROs, vendors, and internal staff meet the highest quality standards per SOPs.

  • Identify and implement processes and standards to improve the effectiveness and efficiency of the internal data management team.

  • Contribute to the strategic decision-making process involving data management issues for ongoing clinical trials. Communicate how data management decisions impact other functional areas.

  • Collaborate cross-functionally to ensure proper alignment around data management deliverables.

  • Provide oversight of CROs and related vendors in the area of data management, including establishing and maintaining key performance metrics. Plan, manage, and oversee relevant CRO budgeted activities.

  • Lead build of clinical databases (EDC), including oversight of CRO and/or internal resources supporting the process.

  • Participate in study setup and initiation procedures such as case report form (CRF) design, database design, edit check design and review, CRF Completion Guidelines, Data Management Plan review and approval, annotated CRF design and User Acceptance Testing, review and approve the Data Transfer Agreements between external data vendors and core labs.

  • Ensure completeness and accuracy of all study documentation with periodic eTMF quality checks. Coordinate and participate in the review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy.

  • Ensure clinical data within EDC and/or other database is of high quality to support data monitoring, interim analysis, and lock/unlock of clinical database.

  • 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.

  • Remain current relative to regulatory requirements, data standards and industry best practices to ensure highest level of compliance and data integrity.

  • Establish optimal relationships with internal customers and colleagues and with new or existing strategic partners and vendors.

  • Direct management and mentoring responsibilities for internal data management team members.

  • 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 clinical trials.

  • 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.

  • Industry experience is essential.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.