Job Overview

　　Perform tasks at site and country level associated with Regulatory, Start-up and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May participate in feasibility and/or site identification activities.

　　Essential Functions

　　• Contracts negotiation with Sites based in France (needed good knowledge of the convention unique).

　　• Ensure adherence to good clinical practice (GCP), standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables, and to project timelines.

　　• Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.

　　• Prepare site regulatory documents, reviewing for completeness and accuracy.

　　• Review, prepare and negotiate site contracts and budgets with sites, where applicable.

　　• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.

　　• Review and provide feedback to management on site performance metrics.

　　• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.

　　• Inform team members of completion of regulatory and contractual documents for individual sites.

　　• Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory /ethics submissions and ICF adaptation and negotiation, in line with project timelines.

　　• Provide local expertise to Clinical Operations Lead and Project team during initial and on-going project timelines planning.

　　• Perform quality control of documents provided by sites.

　　• May have direct contact with sponsors on specific initiatives.

　　• May perform Site Selection Visits if a trained monitor.

　　• May participate in feasibility and/or site identification activities.

　　Qualifications

　　• Degree in scientific discipline or health care preferred.

　　• Minimum of 3 years clinical experience required.

　　• Equivalent combination of education, training and experience may be acceptable.

　　• Knowledge of clinical research process and medical terminology.

　　• Good written and verbal communication skills including good command of English and French language.

　　• Good organizational and problem-solving skills.

　　• Ability to manage multiple priorities within various clinical trials.

　　• Ability to reason independently to assess and recommend specific solutions in clinical settings.

　　• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

　　• Ability to understand electronic data capture including basic data processing functions.

　　• Familiarity with current International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and applicable regulations to the conduct of clinical research.

　　• Ability to mentor other employees.

　　IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

　　IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

　　To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.

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