Join us on our exciting journey! IQVIATM is The Human Data Science CompanyTM, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.
Medical and Scientific Services has an exciting opportunity within Infectious Diseases and Vaccines area medical group. Let your career soar with IQVIA!
The Medical Advisor / Associate Medical Director will provide medical and scientific advisory expertise to all IQVIA divisions as requested. Participate in all aspects of Medical Science involvement on assigned clinical trials in the preparation of and during project delivery lifecycle. Provide medical expertise to business development activities. RESPONSIBILITIES:
The role includes predominantly Medical Monitoring responsibilities with Medical Strategic inputs. Medical Monitoring:
- Primarily serves as regional and/or global 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.
- 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.
- 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.
- Specialty Board certification in Infectious Diseases with minimum of 2 years practicing medical experience in this area is necessary. Ideally experience in clinical trials either as investigator, coinvestigator or from working either for pharma or CRO, ideally as a medical monitor.
- Excellent command of written and spoken English especially in medical terminology
- Strong communication, presentation and interpersonal skills
- Ability to establish and maintain effective working relationships with co-workers, managers and clients in an international environment
- Ability in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility
- Robust and current knowledge of medical, scientific and therapeutic competitive landscape in applicable therapeutic area
- Medical monitoring experience would be an advantage
- May require periodic international travel
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Extensive use of keyboard requiring repetitive motion of fingers.
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIATM