IQVIA is looking to appoint a Medical Advisor/Associate Medical Director to be part of our Medical Services team to deliver medical, clinical and scientific advisory expertise in clinical research studies. You will support compliance with protocol execution from a medical and scientific perspective. Also, you will provide medical expertise during project delivery lifecycles; provide medical support to project teams and investigative sites; clarify protocols and inclusion/exclusion determinations; advise around patient safety issues; perform medical reviews and clarifications of trial-related and post marketing studies Adverse Events; signal detection and aggregated reporting; and conducting project delivery lifecycles (pre-marketing and post-marketing).
Responsibilities:
- Primarily acts as back-up Medical Advisor but may serve as Regional Medical Advisor on 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.
- Contribute to the medical review of the protocol, Investigative Drug Brochure (IDB) and/or Case Report Forms (CRFs).
- Provide therapeutic area/indication training for the project clinical team.
- Attends and may present 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.
Qualifications:
- Medical degree with training in Hematology or Oncology from an accredited and internationally recognized medical school with a curriculum relevant to general medical education.
- Specialty Board certification in relevant specialty area preferred.
- Some years of prior relevant experience in general clinical medicine including experience in the requested applicable medical specialty area or equivalent combination of education, training, and experience.
- Current knowledge of medical, scientific and clinical landscape in applicable therapeutic area.
- Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
- Strong communication, presentation and interpersonal skills, including good command of English language (both written and spoken).
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- May require occasional travel.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.