Atorus
Website:
atorusresearch.com
Job details:
Job Overview
The 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.
Job 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
· Assist with the 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
· Assist with training new team members
· Participate in and attend study team meetings, as required
· Participate in department meetings and initiatives
· Perform other duties as required by the department
Qualifications and Education Requirements
- 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).
· 1+ years’ experience working in pharmaceutical, biotechnology or Contract Research Organization (CRO) preferred
· 1+ years’ experience as a data manager preferred
- Additional relevant work experience will be considered in lieu of formal qualifications
- Knowledge of drug development processes
- 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
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