Sr External Data Manager

Remote from anywhere in Costa Rica

Overview

The 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.

Responsibilities

• Adhere to project timelines
• Ensure electronic vendor data contains all protocol specified parameters and data populates to the specified fields and patients correctly
• Develop the data transfer agreement and/or plan specifications document for vendor data transfers
• Perform validation review of the electronically transmitted data for a sample of total number of patients in the study for loading purposes
• Perform review of external data edit checks, status reports and listings
• 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
• 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
• Review data discrepancies generated by study specific edit checks for external data and perform the subsequent query management process in resolving the data issues
• Ensure team member performance supports project budget and delivery requirements
• Communicate to vendors and client any concerns involving data transfers, data point issues, and validation issues
• Provide guidance and training to External Data Managers and all new Senior External Data Managers
• Participate in and attend study team meetings, as required
• Participate in department meetings and initiatives
• Perform other duties as required by the department

• 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).
• 3-5 years’ experience working in pharmaceutical, biotechnology or Contract Research Organization (CRO) preferred
• Previous experience as a Data Manager preferred
• Minimum 2 years of experience leading external data Management projects
• Global team experience preferred
• Additional relevant work experience will be considered in lieu of formal qualifications
• Broad knowledge of drug development processes
• Understanding of global clinical development budgets and relationship to productivity targets
• Knowledge of effective Clinical Data Management practices focused on External Data
• Previous experience as Data Manager preferred
• Experience with 3rd Party vendor data
• Experience with data transfer agreements and/or plans and data transfer specifications