Regulatory and Start Up Specialist (RSUS)(FSP)
Descripción del trabajo
Regulatory and Start Up Specialist
Work from any location
Must speak Polish and English
Join us on our exciting journey!
IQVIA Clinical Functional Services Partnerships (FSP) business is unique. Our teams are dedicated to a single sponsor partner, where the common goal is quality delivery for our customers.
We set ourselves apart with collaboration and face to face contact both at start up and during the clinical study.
Unique to the FSP model, our team contributes to the pipelines of the specific sponsor and therefore our RSU’s are critical to making the world a healthier place.
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 project timelines.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Perform admissions of regulatory documents.
Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
Perform quality control of documents provided by sites.
Inform team members of completion of regulatory and contractual documents for individual sites.
- Bachelor’s Degree in life sciences or a related field
- 3 years clinical research experience, including 1 year experience in a leadership capacity or equivalent combination of education, training, and experience.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
- Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
- Understanding of regulated clinical trial environment and knowledge of drug development process.
From camaraderie to professional development, working at IQVIA provides unique opportunities to advance your career alongside a group of diverse and talented colleagues.
What is in it for you?
- Global exposure
- Variety of therapeutic areas
- Collaborative and supportive team environment
- Access to cutting-edge in-house technology
- Excellent career development and progression opportunities
- Work-Life Balance
Embrace your curiosity and grow your career in an exciting environment where development is a priority.
Think boldly and disrupt conventional thinking.
Enjoy what you do.
Whatever your career goals, we are here to ensure you get there!
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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