Advanced Group

  • Medical Monitor

    Job Locations US-IL-Deerfield
    Req No.
    2018-9578
    Type
    Regular Full-Time
    Client
    Advanced Clinical
  • Overview

    Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.

    Responsibilities

    The Medical Monitor is responsible for delivery of medical monitoring services, including, but not limited to, working with clinical project teams to monitor the safety of ongoing studies, and support database locks.  The MM will work with the clinical teams to review the safety data including review of MedWatch/CIOMS forms. This individual must have the ability to work and communicate efficiently with internal and external partners.  The MM must be a licensed Medical Doctor (MD) or Doctor of Osteopathy (DO) preferably with experience in Oncology.  A minimum of five (5) years of industry experience and in depth knowledge of, and experience as, a medical monitor for clinical trials (Phase I - III) is necessary.  This individual must possess strong verbal and written communication competencies as well as interpersonal skills with experience participating on project teams, coordinating safety activities and adhering to tight timelines.  The MM will attend regularly scheduled meetings as required and respond to site, sponsor and Health Authority questions. He/she will attend and present at Investigator meetings,  review CRFs,  present study updates as needed, train in-house staff and project teams, design and implement safety monitoring plans, conduct data base listings (DBL) final reviews, review blinded tables, listing & figures (TLFs), review protocol deviations, and participate in all DBL meetings as assigned. The MM will review final TLFs, work with the medical writer(s) to review & revise Clinical Study Report (CSR) documents, review discussion and conclusions, and participate in comment resolution meetings. The MM may present topline results to Sponsors or Competent Authorities. Other tasks may be required as determined by the project.  The position is preferably based in the Chicago, IL, area but working remotely with occasional face to face meetings is acceptable depending on business needs. He/she will need to be present in the Deerfield, IL, office for initial onboarding/training.

     

    Essential Functions

    • Assist with RFP/RFI completion and attend sales meetings as requested by Business Development
    • Oversees the management of medical monitoring during the course of clinical trials and projects
    • Oversees medical review of key clinical documents, individual case safety reports, and medical or safety-related regulatory documents
    • Provides support and input into the planning, design, preparation, initiation, and execution of study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
    • May participate in the evaluation and selection of investigators and study sites as well as analysis of medical activities
    • Ensures delivery of medical/clinical direction to investigative sites per contract deliverables
    • Prepares medical and safety plans for clinical trials/services
    • Oversees collection, review, guidance and manages overall safety case processing as dictated by client contracts
    • Oversees reviews and directs medical and safety sections of regulatory document submissions
    • May participate in Investigator meetings
    • Develops and assists other staff in the development of processes, timelines, planning, and strategy
    • Facilitates collaboration and communication with medical/scientific personnel and ensures that the most current research information is accessible for review

    Qualifications

    This individual requires an excellent understanding of the clinical/pharmaceutical process so as to effectively communicate and create required deliverables. Possesses advanced knowledge of, and ability to, apply ICH GCP and all applicable FDA and international pharmacovigilance regulations and guidelines. Possesses exceptional leadership skills and proven industry vision.  

    Requires effective negotiation and interpersonal communication skills to interact with a variety of peers and constituents. Must have the ability to understand complex clinical and statistical data and issues from an analytic standpoint.

    • Education:  Medical Doctor (MD) or Doctor of Osteopathy (DO) from an accredited university.  Specialty in oncology preferred.
    • Certification:  Preferably board certified in the US.
    • Experience:  Minimum of five (5) years of clinical research and medical/safety management experience in the pharmaceutical industry

     

    What’s in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:

     

    For a complete list of all of our job openings, please visit Advanced Group’s career site here.

     

    It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.


    This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job.  If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

     

     

     

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