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Manager, Oncology Clinical Data Review - REMOTE

Company: Precision Medicine Group
Location: Garland
Posted on: January 13, 2022

Job Description:

Precision medicine is revolutionizing the charge on cancer-and we are passionate about helping you harness its power. We strike tumors on a molecular level using biomarkers to link specific mutations to specific treatments. We combine deep science with deep data from advanced technological platforms, then layer on specialized expertise in the design and execution of targeted, adaptive clinical trials.

We offer an excellent compensation package, value our company culture and career advancement opportunities. This position is 100% remote!

The Manager will focus on the early and continuing scientific review of clinical data in various formats by applying the protocol and/or other applicable references along with oncology standards for the indication being studied to support overall data quality and consistency, allowing the for insights to support a continuous risk management approach. Coordinate development of direct reports by setting goals, conducting performance reviews, crafting development plans, mentoring, and coaching

Responsibilities

Serves as the functional lead (core team member) representing CSAI-OS on assigned project team(s)

  • Lead all aspects of and supports CSAI-OS Scientists in the review of subject data for accuracy per protocol, associated references and oncology standards of care and principles.
  • Coordinates and conducts targeted reviews and analyses of clinical trial data sources early and ongoing throughout the trial to ensure consistency, integrity and accuracy based on CSAI-OS project specific review guidelines with an emphasis on scientific and clinical sense
  • Develops and maintains a good working relationship with internal and external project team members, serving as an ambassador to promote Precision's high quality and ethical image in accordance with the company Core Values.
  • Serves as a resource for project teams regarding scientific, clinical, oncology related questions supported by Medical Monitoring
  • Assesses routine status updates on findings and intensifies issues as appropriate with project team and CSAI-OS Management
  • Supports the identification of quality risks and issues and recommends corrective action plans as needed to address deficiencies in performance throughout the life of the project
  • Leads and/or conducts UAT of CSAI-OS programming output and participates in EDC UAT supporting the CSAI-OS functionality as applicable
  • Provides review of the protocol from a scientific-operational perspective detailed understanding of assigned protocol and protocol requirements
  • Provides indication specific input into data capture and other clinical trial document development (e.g., EDC specifications, completion guidelines, edit checks, review guidelines, etc.)
  • Issues and resolves queries in various EDC systems when needed
    Qualifications

    Minimum Required:
    • Bachelor's degree or equivalent combination of education/experience in science or healthcare field with proficiency in medical terminology.
    • At least five (5) years (Manager level) or eight (8) years (Sr. Manager level) in clinical operations, data management, safety or related field in either the CRO or pharmaceutical industry with a minimum of three (3) years on-site monitoring experience and/or data review experience
    • Strong oncology therapeutic experience required with ability to apply knowledge to the source data
    • Supervisory experience executing process, people and/or teams
    • Mastery level skill set in oncology clinical standards including the application of disease assessment criteria, standard of care, grading criteria, etc.
    • Experience with electronic data capture systems (EDC) and data visualization tools
      Preferred
      • Medical related degree, RN, OCN, RPH, PharmD, etc.
        Any data provided as a part of this application will be stored in accordance with our Privacy Policy .

        Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. - 2020 Precision Medicine Group, LLC

        If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com .

Keywords: Precision Medicine Group, Garland , Manager, Oncology Clinical Data Review - REMOTE, Executive , Garland, Texas

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