Data by YubHub
Senior Project Set-Up Coordinator, Laboratory Services
IQVIA
Sponsorship not confirmed
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About the job
We are seeking a Senior Project Set-Up Coordinator, Laboratory Services to provide project-related support, including the design, loading, configuration, and validation of laboratory databases using Clinical Trial Management Systems (CTMS). The role ensures work is conducted in accordance with standard operating procedures, company policies, and industry best practices. The incumbent is accountable for the quality, accuracy, and integrity of database configuration activities. Responsibilities: Assist with study validation activities. Research and resolve issues, gather relevant information, and liaise with laboratory teams to ensure projects are set up in accordance with established procedures and customer requirements. Configure project databases, where applicable. Maintain complete, accurate, and up-to-date project documentation. Keep Set-Up Managers, Project Managers, and other stakeholders informed of issues that may affect the successful execution of projects. Coordinate meetings with relevant colleagues and internal departments, including planning and handover meetings. Participate in local and global continuous improvement initiatives as directed by the process improvement team. Participate in internal audits as required. Communicate with study sponsors as needed, including the exchange of factual information. Assist in the development of database design requirements for study protocols and protocol amendments. Contribute to project planning activities, including timeline development, regulatory milestone tracking, and risk identification. Manage the set-up process for low-complexity studies, where applicable. Mentor and assist in the training of less experienced staff. Perform all activities in accordance with the ICH E6 Guideline for Good Clinical Practice (GCP). Minimum Required Education and Experience: Bachelor's degree in Life Sciences or a related field preferred. An equivalent combination of education, training, and experience may be considered in lieu of a degree. Minimum one year of relevant experience in the Clinical, Medical, or Healthcare industry, or an equivalent combination of education, training, and experience. Required Knowledge, Skills, and Abilities: Strong organisational and coordination skills. Demonstrated commitment to quality, accuracy, and attention to detail. Strong verbal and written communication skills. Proficiency with computer applications, including word processing and spreadsheet software. Knowledge of Clinical Trial Management Systems (CTMS) is preferred. Ability to work effectively in a fast-paced environment and manage multiple priorities. Ability to establish and maintain effective working relationships with colleagues, managers, and clients. Knowledge of laboratory processes and computer systems is considered an asset. Language Requirement: Functional knowledge of English, both written and spoken, is necessary to perform the duties of this position. Job Data by YubHub .
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