Regulatory and Start Up Specialist - London, United Kingdom - Novasyte
Description
Job Overview
Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines.
Essential Functions
- 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.
- Perform start up and site activation 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.
- 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, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and ongoing project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.
Qualifications:
- Bachelor's Degree in life sciences or a related field and 3 years' clinical research or other relevant experience; or equivalent combination of education, training and experience.
- 3 years clinical research experience, including 1 year experience in a leadership capacity. Equivalent combination of education, training and experience.
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.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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 atMore jobs from Novasyte
-
Associate Director Client Operations
Livingston, United Kingdom - 2 weeks ago
-
Senior Consultant, Emea Brand
London, United Kingdom - 6 days ago
-
Clinical Research Coordinator
Belfast, United Kingdom - 6 days ago
-
Lab Assistant
Livingston, United Kingdom - 2 weeks ago
-
Laboratory Technical Specialist
Livingston, United Kingdom - 2 weeks ago
-
Lab Technical Support Specialist
Livingston, United Kingdom - 1 week ago