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17851-Lab Project Set-Up Co-ordinator
IQVIA Holdings Inc.
Various Locations
Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health. A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.
Job Overview
Provide pre-launch database support; assist with designing, loading, and validation of Lab databases using Lab Trials Management System [examples QLIQVIA, NewLIQVIA, TOPCAT, Encompass]; ensure work is conducted in line with standard operating procedures, policies and good practice.
Provide pre-launch database support; assist with designing, loading, and validation of Lab databases using Lab Trials Management System [examples QLIQVIA, NewLIQVIA, TOPCAT, Encompass]; ensure work is conducted in line with standard operating procedures, policies and good practice.
Essential Functions
• Configure project databases
• Input data into the databases adhering to design specifications.
• Support online protocols and amendments.
• Perform a database configuration review and assist with validation of database specifications.
• Research problems, gather information, and liaise with lab colleagues to help ensure projects are set-up in line with established procedures and customer requirements.
• Maintain project documentation files.
• Keep Project Managers and other relevant staff informed of any issues that may affect the smooth running of the project.
• Coordinate meetings with relevant colleagues and internal departments (e.g. planning and handover meetings).
• Develop solutions for routine project related issues and problems, within a limited scope.
• Participate in local and global improvement projects as defined by the relevant process improvement management team.
• Participate in internal audits, as required.
• May have occasional, limited contact with study Sponsor(s) (e.g. exchanging factual information).
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
• Configure project databases
• Input data into the databases adhering to design specifications.
• Support online protocols and amendments.
• Perform a database configuration review and assist with validation of database specifications.
• Research problems, gather information, and liaise with lab colleagues to help ensure projects are set-up in line with established procedures and customer requirements.
• Maintain project documentation files.
• Keep Project Managers and other relevant staff informed of any issues that may affect the smooth running of the project.
• Coordinate meetings with relevant colleagues and internal departments (e.g. planning and handover meetings).
• Develop solutions for routine project related issues and problems, within a limited scope.
• Participate in local and global improvement projects as defined by the relevant process improvement management team.
• Participate in internal audits, as required.
• May have occasional, limited contact with study Sponsor(s) (e.g. exchanging factual information).
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
Qualifications
• High School Diploma or equivalent
• 4 years' relevant experience Req Or
• Equivalent combination of education, training and experience.
•
• High School Diploma or equivalent
• 4 years' relevant experience Req Or
• Equivalent combination of education, training and experience.
•
Job posted: 2020-10-02
