Medical Monitor Director
Michael Page
Ciudad Autónoma de Buenos Aires, Argentina
hace 4 días

Descripción de la oferta

The role includes both Medical Monitoring responsibilities and Medical Strategic inputs

Medical Monitoring :

  • Primarily serves as Global Medical Advisor on oncology and / or hematology clinical studies.
  • Serves as Scientific Advisor and provides guidance to Project Leaders on the medical and scientific aspects of assigned projects.
  • Provides medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion / exclusion determinations, and issues of patient safety and / or eligibility.
  • Performs medical review of the protocol, Investigative Drug Brochure (IDB), and / or Case Report Forms (CRFs).
  • Provides therapeutic area / indication training for the project clinical team.
  • Attends and presents at Investigator Meetings.
  • Performs review and clarification of trial-related Adverse Events (AEs).
  • May perform medical case review of Serious Adverse Events (SAEs), including review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
  • May provide medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
  • May perform medical review of adverse event coding.
  • Performs review of the Clinical Study Report (CSR) and patient narratives.
  • Attends Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
  • Available 24 hours per day, 7 days per week to respond to urgent protocol-related issues at the investigative sites.
  • Medical Strategy :

  • Provides expert advises to the development of medically sounded delivery strategies for small to large and / or complex multi-
  • region studies in partnership with sales and other functions responsible for business development activities.

  • Responsible for the development of the medically related aspects of client proposals including the budget related to medical monitoring.
  • Provides medical and scientific advises to key internal stakeholders developing proposals : this may include, but is not limited to, reviewing the protocol for scientific / regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
  • Participates in strategic business development activities including presentations to prospective clients.
  • Maintains awareness of industry development and may author related publications.
  • May serve as Regional / Multi-regional / Global Therapeutic Lead for specific indication(s)
  • Page Group Argentina is acting as an Employment Agency in relation to this vacancy.

    Perfil buscado (Hombre / Mujer)

  • Medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with a medical license, or equivalent, from the country or region in which he / she resides and works is required.
  • Board Certification in Oncology and / or Hematology.
  • Fluent English.
  • Minimum 5 years of CRO and / or Pharma industry experience with a Medical Director grade or similar, in addition to experience as Clinical investigator in clinical studies over some years (desirable).
  • Proven skills & abilities :
  • Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area
  • Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
  • Team orientation. Strong communication, presentation and interpersonal skills.
  • Business Acumen.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.
  • Attractive package

    Medical Monitor Director De : correo electrónico

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