PURPOSE
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.
RESPONSIBILITIES 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:o Patient profiles
o Safety listings
o Other data listings, including Efficacy listings
o Coding for Adverse Events (AEs)
o Concomitant medicationsParticipate in the preparation of medical monitoring plans in collaboration with Drug Safety and Medical Data Review teams.Respond to protocol questions/CRAs/Sites under direction and supervision of the global study TMA.Collaborate with Project Leads and Contract Analysts to review and finalize the contract/budget and future COs.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:o Safety listings review and queries generation, where appropriate
o Protocol Deviations Log review
o Concomitant medications and codingCoordinate activities and 'flow of information' with Medical Safety Advisor, Medical Data Reviewer and Medical Surveillance Specialist during study start up and throughout the project lifecycle, such as:o Participate in the preparation of information and summary slides for client mtg
o Manage and track action items from Medical Delivery Services Kick-off mtgSupport 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:o Investigator meetingso Protocol training
o CRA training
o Program kick-off meetingsPerform literature searches and summarize data/information including:o Disease area research
o Standard of careo Results from clinical trials in specific indicationsWhere appropriate, contributes to:o protocol concept development by providing input to the Medical Writero clinical study reports by providing input to the Medical Writer
o clinical sections of Regulatory documents by providing medical team inputContribute to Medical and Scientific Services and other initiatives that support the advancement of IQVIA therapeutic capabilities REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Understanding of relevant therapeutic areaUnderstanding of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelinesKnowledge and experience to conduct activities in compliance with regional/global regulatory requirementsUnderstanding of clinical trial design and executionGood communication, interpersonal, negotiating and reporting skillsDemonstrated proficiency in using systems and technologies to achieve work objectivesMedical/clinical knowledge to independently review adverse event dataAbility to work on and collaborate with colleagues on global teamsAbility to proactively predict issues and solve problemsAbility to positively influence internal and external stakeholders, including internal global and matrix teamsAbility to balance multiple prioritiesMINIMUM REQUIRED EDUCATION AND EXPERIENCE Master's 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) experienceAdvanced scientific degree preferred (PhD, PharmD)IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at https://jobs.iqvia.com
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