Pharm-Olam International

  • Medical Monitor

    Job Locations US | US | US | US | US | CA-ON-Mississauga
    Job ID
    2018-1767
    Category
    MA - Medical Monitors
  • Overview

    About Pharm-Olam International:

     

    Pharm-Olam International is a mid-size Contract Research Organization (CRO) that has a massive global reach, then look no further, because Pharm-Olam International offers all of this and more. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. Pharm-Olam has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

     

    Summary

     

    Works with an international team of medical monitors and safety officers to ensure the medical/clinical integrity and quality of studies conducted by Pharm-Olam International are conducted in compliance with all applicable competent authority regulations and international Good Clinical Practices (GCP).  Serves as the medical monitor contact in study protocols to investigators and study sites team regarding protocol compliance issues and safety of the subjects enrolled.   Advises and assures investigators, project teams, and clients on safety issues arising from medicinal products, devices and study designs undertaken by Pharm-Olam.  Works with internal team members, senior management and business development on issues and questions of any medical /clinical nature.  Reviews SAEs, SUSARs and AEs reports and writes safety narratives in accordance with all applicable competent authority regulations and ICH E2 reporting standards.  Ensures that protocols, investigator’s brochures, clinical trial reports written by Pharm-OIam are appropriately reviewed and approved in accordance with Pharm-Olam’s SOPs and good medical practices.

    Responsibilities

    • Oversees the safety aspects of assigned clinical trials managed by Pharm-OIam, including adverse events, safety reporting and laboratory testing in consultation with the project manager.  When appropriate, assists the project manager in discussions with clients on safety issues or concerns that may have arisen.
    • Prepares the SAE and Safety Reporting section of the Project Plans for studies conducted by Pharm-Olam prior to the start of the study.
    • Writes IND safety narratives in accordance with FDA and ICH E2 reporting standards and oversees the processing of SAEs, SUSARs, etc. to clients and to regulatory agencies.
    • Serves as the medical monitor contact in study protocols
    • Provide Medical reviews of SAE information.
    • Provide ongoing tutoring/medical education to DSOs and Regulatory Liaison.
    • Provides 24/7 MM coverage
    • Reviews and addresses all medical alerts in assigned studies.
    • Reviews clinical laboratory data on selected studies for safety tends or signals.
    • Assists clinical data management with MedDRA and WHO DD coding.
    • Conducts the medical reviews of safety listings and clinical trial data in assigned studies.
    • Assists by reviewing or writing safety section of a clinical trial report and other safety reports including post marketing reports (e.g. PSUR)
    • Reviews investigational brochures, Protocols or other study-related documents produced by Pharm-Olam for accuracy, completeness and comprehension and also to provide scientific input as needed.
    • Assists in the set up and conduct of Data Safety bodies (DSMB, DMB or similar) s as required by Pharm-Olam.
    • Assists with protocol interpretation and, as needed, contacts others to ensure appropriateness of decisions arising from such interpretation.
    • May advice and assist clients on product development, study designs, endpoint analyses and the feasibility of conducting Phase I to IV clinical trials in countries proposed by Pharm-OIam. Liaise with country managers and department heads at Pharm-OIam as needed to meet this task.
    • With the assistance of the country manager, advises on federal and local laws, regulations or medical practices affecting the clinical trials managed by Pharm-Olam.  Where appropriate, maintains contact with various medical consultants.
    • May provide therapeutic consultation in support of the scientific, medical and regulatory operations of the company. Including medical assessments on a consultative basis for post marketing activities (e.g. product labelling, health hazard evaluations etc.
    • Provides direction to the medical writing personnel and activities of the company.
    • Attends and participates in Investigators’ meeting and other committees, meetings as requested. 
    • Attends and presents at major therapeutic conferences and drug development conferences.
    • Supports the company’s growth through finding new clients and developing existing accounts in Business Development.
    • Supports marketing and promoting the company through writing articles, conducting journal interviews, etc.
    • Prepares and delivers PVG, various medical/scientific and therapeutic area training.

     

    Working Relationships:

    • Works with Clinical Research Associates, Project Managers, and ADPMs to support cooperative exchange of study and safety data.

    Qualifications

    • At least three years experience in role of MM (except in exceptional circumstances)
    • Able to make medical decisions for the study independently and can act as primary MM on studies
    • Able to review relevant medical documentation to give assistance to Business Development
    • In possession of Medical degree
    • Previous experience within a clinical environment
    • Completion all of Pharm-Olam SOPs during first year in role
    • High level of interpersonal and presentational skills

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