Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

A day in the Life:Coordinates and reviews safety data, utilizing line listings, company dashboard(s) and/or other visualization tools. Reviews data for safety trends, coding consistencies, and potential follow up with investigator sites. Identifies potential issues and resolves or escalates as appropriateReviews safety data and may provide summations for safety review meetings. May review designated sections of aggregate reports.May help to create/review safety and medical management plan(s) on studies (as applicable) and ensures that the processes included in plan documents are reflective of the contract and services requested.May help Manage routine project implementation, forecasting and coordination, including review of metrics and budget considerations.Monitors the status of the data review and escalates any delays and/or risks to all stakeholders, including study leads.May present at business development, client, and investigator meetings and participate in strategy/business development calls.Resolves complex problems through in-depth evaluation of various factors and offers solutions.May serve as the primary point of contact for clinical/data management project teams.May assist management in training and mentoring.

EducationBachelors degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN

ExperiencePrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years), to include 2+ years clinical safety experience (clinical research monitoring, or pharmacovigilance or combination of clinical research monitoring and pharmacovigilance)

Knowledge, Skills, AbilitiesKnowledge of GCPs for medical oversight of clinical trials and SAE processingKnowledge of drug development and safety reportingKnowledge of safety data trending to include codingWorking knowledge of biostatistics, data management and clinical proceduresStrong problem solving and critical thinking skillsGood oral and written communication skillsGood Strong attention to detailAbility to work in a collaborative team environmentAbility to maintain a positive and professional demeanor in challenging circumstances