Job Overview The Clinical Scientist supports medical monitoring and scientific tasks on projects under the guidance of Therapeutic Medical Advisors (TMA) and in collaboration with the cross functional project team. These activities enable the use of high quality, scientific data to make timely decisions during clinical study planning, execution, analysis, and reporting. This includes CRA/investigative site support as well as advanced safety and data analytics.Essential FunctionsRespond to protocol questions/CRAs/Sites under direction and supervision of the global study TMA.Collaborate with the Medical and Safety Data Review teams to ensure timely progress and consistency with deliverables associated with medical data review (e.g., summary of clinical trial data) and where appropriate review of:Patient profilesSafety listings, other Data listings including Efficacy listingsCoding for Adverse Events (AEs) and concomitant medicationsParticipate in the preparation of medical monitoring plans in collaboration with DrugSupport project budget reviews.Prepare for and where required attend Safety review meetings with Sponsors under the supervision of the global Medical Advisor and the Medical Safety physician.Covering Areas Such As:Safety listings review and queries generation where appropriateProtocol Deviations Log reviewConcomitant medications & codingCoordinate activities and 'flow of information' with Medical Safety Advisor, Medical DataReviewer and Medical Surveillance Specialist during study start up andThroughout The Project Lifecycle, Such As:Participate in the preparation of information and summary slides for client meetingsManage and track action items from Medical Delivery Services Kick-off Meetings (KOMs)Support quality assurance and other audits that involve the review of medical services (e.g., preparation of files, tracking and management of audit follow up actions and preventatives).Conduct electronic Trial Master File (eTMF) maintenance in relation to Medical and Scientific Services activities.Prepare and deliver presentation materials under the supervision and review of the global TMA, such as:Investigator meetingsProtocol and/or CRA trainingAuditsProgram kick-off meetingsPerform literature searches and summarize data/information including:Disease area researchStandard of careResults from clinical trials in specific indicationsWhere appropriate, contributes to:Protocol concept development by providing input to the Medical WriterClinical study reports by providing input to the Medical WriterClinical sections of Regulatory documents by providing medical team inputAssist with protocol development and review for early engagement/partnership programs.QualificationsStrong scientific background, PhD or PharmD preferred, advanced nursing or other advanced biomedical degree with post‐graduate training and/or relevant work experience.Minimum 5 years of clinical trial experience, including a high‐skill level of data analysis interpretation.Master Degree in a biomedical, life science or similar scientific field 3 years of clinical trial experience, including 2 years of directly relevant therapeutic area(s) experience will also be considered.English language on business communication level (C1).Experience with the following therapeutic areas: Oncology, Neurology, CNS, Internal Medicine.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.comIQVIA 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.#J-18808-Ljbffr