{"start":0,"count":1,"data":[{"publicDescription":"<strong>Sr External Data Manager</strong><br>\nFull-time<br>\nRemote from anywhere in Costa Rica #LI-Remote<br>\n<br>\nOVERVIEW<br>\nThe Senior External Data Manager is responsible for the review, maintenance, and update of external vendor data received from the central vendor, local laboratories and/or any other external vendor in accordance with Atorus and/or sponsor standard operating procedures (SOPs), Good Clinical Practice (GCP), ICH Guidelines and sponsor requirements.<br>\n<br>\nRESPONSIBILITIES<br>\n•    Adhere to project timelines <br>\n•    Ensure electronic vendor data contains all protocol specified parameters and data populates to the specified fields and patients correctly <br>\n•    Develop the data transfer agreement and/or plan specifications document for vendor data transfers <br>\n•    Perform validation review of the electronically transmitted data for a sample of total number of patients in the study for loading purposes<br>\n•    Perform review of external data edit checks, status reports and listings<br>\n•    Work with clinical staff to obtain local laboratory normal ranges for all sites. Research and resolve discrepant information concerning normal ranges and maintain proper documentation<br>\n•    Edit and perform QC for local laboratory normal ranges. Verify that normal ranges are properly attached to patient results in the local lab data collection module<br>\n•    Review data discrepancies generated by study specific edit checks for external data and perform the subsequent query management process in resolving the data issues<br>\n•    Ensure team member performance supports project budget and delivery requirements<br>\n•    Communicate to vendors and client any concerns involving data transfers, data point issues, and validation issues<br>\n•    Provide guidance and training to External Data Managers and all new Senior External Data Managers<br>\n•    Participate in and attend study team meetings, as required<br>\n•    Participate in department meetings and initiatives<br>\n•    Perform other duties as required by the department<br>\n<br>\nREQUIREMENTS<br>\n•    University/college degree (life science, pharmacy or related subject preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).<br>\n•    3-5 years’ experience working in pharmaceutical, biotechnology or Contract Research Organization (CRO) preferred<br>\n•    Previous experience as a Data Manager preferred<br>\n•    Minimum 2 years of experience leading external data Management projects<br>\n•    Global team experience preferred<br>\n•    Additional relevant work experience will be considered in lieu of formal qualifications<br>\n•    Broad knowledge of drug development processes<br>\n•    Understanding of global clinical development budgets and relationship to productivity targets<br>\n•    Knowledge of effective Clinical Data Management practices focused on External Data<br>\n•    Previous experience as Data Manager preferred<br>\n•    Experience with 3rd Party vendor data<br>\n•    Experience with data transfer agreements and/or plans and data transfer specifications","id":510,"title":"Sr External Data Manager"}]}