Responsible for medical data review and medical safety case processing and related safety activities. Performs review of medical data to ensure medical/scientific plausibility and to employ medical assessment and knowledge. Also, provides medical expertise in assigned trials and standalone safety projects. Train and mentor team members in medical and safety review activities.
Attend and present Medical Data Review activities during the client Kick Off Meeting.
Write Medical Data Review Plan in collaboration with the Medical Monitor and in accordance with the client input.
Create protocol specific Medical Data Review Guide in collaboration with the Medical Monitor.
Participate in the internal eCRF review meeting and contribute to the development of eCRF.
Define data capture requirements as required throughout the study that are consistent with the protocol and reporting needs.
Contribute to the Data Review Plan.
Provide requirements and specifications for programming of data listings.
Collaborate with Clinical Science and Data Operations teams in the development of Qlik Sense builds and protocol specific customizations for patient profiles.
Participate in activities involving risk assessment and measuring the effectiveness of risk minimization measures.
Provide medical review of data listings and patient profiles, including but not limited to, adverse events, concomitant medications, medical history, labs, vitals, ECGs, eligibility criteria, efficacy assessments and study specific assessments.
Prepare protocol specific templates for the periodic summary reports for safety data, including the Safety Trend Analysis Report (STAR) or Safety Review Committee slide presentations, in collaboration with the Medical Monitor.
Compose the STAR report during the study according to scope and timelines.
Conduct in-stream data trend analysis in support of data quality and integrity including protocol compliance and targeted review of patient data.
Prepare periodic MDR summary reports or presentations if requested.
Medical review and case assessment of SAEs including assessment and coding of preferred term, medical history, indications of concomitant medications and treatment medications; determination of seriousness, causality, expectedness; narrative review; query generation and follow up of SAE till case closure.
Compose sponsor comment/summary.
Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements.
Medical degree from an accredited, internationally recognized medical school.
Recipient of a medical license from the country or region in which he/she currently resides or previously resided.
5 years of experience in the practice of medicine in a clinical or academic setting which may include specialty medical training or fellowship.
Minimum of 3 years of experience in Medical Data Review and/or Medical Safety Review.
Advanced English level.
Knowledge of MedRA, WhoDrug.
Previous experience in Medidata Rave, Inform.
Previous experience in Argus Safety.
Solid experience with Excel, Power Point and other data visualization tools as Spotfire, J Review, others.
Availability to work in a flexible global schedule.
