Site Activation Specialist - Paris, France - Novasyte
Description
IQVIA's Country Site Activation team are a global network who identify and activate sites to the highest quality to ensure patients on Clinical trials have access to safe and effective medication.
We are leaders in innovation and first to new technologies meaning a vast amount of career development opportunities are available.
Our Site Activation Specialists work under moderate supervision, executing the feasibility, site identification, regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level.
You will prepare and manage site documentation; reviews and negotiates site documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines.
- Serve as a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary
- Review documents for completeness, consistency and accuracy, under guidance of senior staff
- Prepare site documents, reviewing for completeness and accuracy
- Inform team members of completion of regulatory contractual. and other documents for individual sites
- Distribute completed documents to sites and internal project team members
- Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information
- Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents
- Bachelor's Degree in Life Science or related field
- Fluent in French language
- Fluent/ native language capabilities, including English
- Ability to work independently to problemsolve collaboratively and to raise issues appropriately as needed
- Good interpersonal communication and organizational skills to establish and maintain effective working relationships with coworkers, managers and sponsors
- Ability to handle change and ambiguity
- Ability to work on multiple projects
- Knowledge of clinical trial environment and drug development process advantageous
LI-Hybrid
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 atPlus d'emplois de Novasyte
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