Assoc Director, Medical Data Review (Homebased - Europe) - Iqvia Biotech

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The IQVIA Biotech Associate Director, Medical Data Review provides medical data review expertise for clinical research studies, leading a team of medical data review staff to conduct analysis of medical data in order to ensure data quality. The goal of the Associate Director, Medical Data Review is to use expert skills to utilize quality medical data review products to guide and perform medical data review services that meet sponsors’ needs.The IQVIA Biotech Associate Director, Medical Data Review will lead a team of medical data review staff in support of IQVIA Biotech Medical Monitors in the delivery of medical data review to sponsors. The IQVIA Biotech Associate Director, Medical Data Review will be responsible leading the design and execution of key medical data review activities for clinical studies. These will include the development of study specific medical data review plans for studies as requested by the Director, Medical Data Review or designee, or Medical Director, and include recommendations for and creation of specific tools and data review platforms for each study. The Associate Director, Medical Data Review will lead discussions on medical data review and analytics project requirements and strategic planning, providing  support at client meetings including bid defenses, Client Alignment Meetings, and Kick Off Meetings, and provide guidance and recommendations regarding the review of medical data obtained during the course of the study.    The Associate Director, Medical Data Review can train team members on the following, as well as perform the tasks of creating a Medical Data Review Plan, defining data capture requirements; identification  of anomalies in patient-reported data; identification of  potential safety signals and creation of safety trend analysis reports and performance of other study specific medical data review tasks.The Associate Director, Medical Data Review may also train staff and/or perform the following: defining data capture requirements; identification of anomalies in patient-reported data; and review and identification of inaccuracies and while ensuring that all necessary supporting information is provided. They may also perform other unspecified tasks in support of the IQVIA Biotech Medical Department at the request of the Director, Medical Data Review or IQVIA Biotech Vice President, Medical.    Job Profile JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES::May obtain literature search to acquire background information for study proposals, preparation of training sessions, and interpretation of clinical data, report writing, etc.Participation in a variety of team quality improvement efforts as necessaryPerform other related duties as assigned or requested by the Director, Medical Data Review or designee, Vice President, MedicalSKILLS, AND to serve as a people managerAbility to work in partnership with a multidisciplinary group of colleaguesOutstanding ability to work independently with minimal supervisionAbility to work effectively within a team and matrix environment, including coworkers, managers and clientsAbility to organize and work efficiently on several projects, each with specific requirements and/or shifting prioritiesExcellent oral and written communications skills and interpersonal skillsOutstanding customer focus skills for internal and external team membersAttention to detailStrong analytical skills and understanding of medical/clinical dataAbility to proactively identify issues of significanceWorking knowledge of medical terminology, pharmacology, anatomy, and physiologyMedical and operational focus towards metrics and status information, and aptitude to take appropriate actions for appropriate resolutionExcellent organizational and problem-solving skillsAbility to work on multiple projects and manage competing prioritiesAbility to plan and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time-based metricsExcellent coaching skillsMINIMUM RECRUITMENT 's Degree required; clinical, biological, or related fieldMedical Training preferred, e.g. MD, Physician Assistant or Nurse Practitioner degree10 years’ combined education plus work experience in clinical research related field; e.g.: clinical data sciences/medical data review at a CRO, pharmaceutical company or other medical research environment including people management experienceMinimum 1-3 years of biopharmaceutical industry experience or academic experience in clinical research and/or drug developmentAdvanced knowledge of Medical Data Review processes and systemsSolid understanding of clinical drug development processCRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA to travel domestically and internationally as requiredVery limited physical effort required to perform normal job duties#LI-AP22#LI-RemAt IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at .Full time

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