Experienced Regulatory & Start-Up Specialist
The IQVIA Research and Development Solutions team is focused on helping our healthcare customers to find innovative treatments solutions for patients with the common, large or rarest illnesses. To be part of the Regulatory & Start-Up team will help them to decrease the site activation time and help the site to be ready to recruit patients faster. We seek dynamic and motivated people who truly want to make a difference in the life sciences industry. At IQVIA, we look for the very best people and give them meaningful work to do. We don’t simply think about careers, we think about contributions.
The RSU specialist will have the following responsibilities :
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.
- Perform Start-up and site activations 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, if applicable.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics, ICF and IP Release documents, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
The RSU specialist has :
- Bachelor’s degree in life sciences or a related field and 4 year’s clinical research or other relevant experience.
- 2-3 years of EC/RA submissions and /or contract negotiations and managements
- In-depth knowledge of clinical systems, procedures and corporate standards.
- Effective communication, organizational, planning, interpersonal skills.
- Ability to work independently on multiple projects and to effectively prioritize tasks.
- Knowledge and ability to apply GCP/ICH and applicable regulatory requirements including local regulations, SOPs and company’s corporate standards.
- Ability to establish and maintain effective working relationships with coworkers, managers and customers.
The position is located in France, home-based or office-based in La Défense.
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
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