Essential Functions
● The role includes predominantly Medical Monitoring responsibilities with Medical Strategic input involvement as requested.
● Medical Monitoring:
●Primarily serves as Global and /or Regional Medical Advisor on assigned projects.
●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.
●Attends and presents at bid defense meeting, as required.
●Participates in strategic business development activities including presentations to prospective clients.
●Maintains awareness of industry development and may author related publications.
● Requires periodic regional and international travel.
Qualifications
● Other 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, plus a minimum of 5 years' experience in clinical medicine. Specialty Board certification in Respiratory medicine is required. Req
● Ideally, candidate will have a minimum 2 years clinical trials experience as an investigator or medical /clinical expert in the Pharma, CRO, or Biotech industry.
● Ability to establish and maintain effective working relationships with coworkers, managers and clients.
● Strong communication, presentation and interpersonal skills, including good command of English language (both written and spoken).
● Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
● Proven skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.