Job Overview
Provide project related support; assist with designing, loading, and validation of Lab databases using Clinical Trials Management System(s); ensure work is conducted in line with standard operating procedures, policies and good practice. Accountability and ownership for the quality of database configuration.
Essential Functions
• Assist with study validation activities
• Research problems, gather information, and liaise with lab colleagues to help ensure projects are set-up in line with established procedures and customer requirements
• Configure project database, where applicable
• Maintain accurate project documentation files
• Keep Setup Managers, 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)
• Participate in local and global improvement projects as defined by the relevant process improvement management team
• Participate in internal audits, as required
• Communicate with study Sponsor(s) as needed (e.g. exchanging factual information)
• Assist in the development of database design requirements for protocols and protocol amendments
• Contribute to project planning, such as creating accurate project timelines, complying with regulatory steps, and identifying potential project related issues
• Manage the set-up process for a low complexity study, where applicable. Mentor and assist in training more junior staff
• Work performed is in accordance with ICH E6 Guideline for Good Clinical Practice.
Qualifications
• High School Diploma or equivalent Req And
• Bachelor's Degree Life Sciences or related field Pref
• Minimum 1 year relevant experience in the Clinical, Medical or Healthcare industry.
• r equivalent combination of education, training and experience.
• Posses strong organizational and coordination skills.
• Proven track record of quality, accuracy and attention to detail.
• Good written and verbal communication skills including good command of English language.
• Computer proficiency in word processing and spreadsheet applications.
• Posses enhanced technical and operational knowledge, especially in the area of Clinical Trial Management Systems (preferred).
• Demonstrated ability to work in a fast-paced environment.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Knowledge of Laboratory processes and computer systems helpful.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.