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.
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.
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.
Medical Monitor Director De : correo electrónico
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