When you work for Quintiles you work for the world's leading Pharmaceutical Services Company. We offer product development and commercialisation services to the Pharmaceutical, Biotechnology and Medical Devices industries. Our leading-edge capabilities provide healthcare companies with the potential to bring new medicines/devices through development and registration to the market place more quickly, with supporting medical and drug data that will significantly advance the cost effectiveness and quality of healthcare provision. Of the world's top 30 best-selling drugs, Quintiles has helped to develop or commercialise every single one.
Quintiles Study Start Up Group ensures fast patient recruitment and start-up for both local studies and complex multi-site, multinational studies. These exciting and challenging roles will give you the opportunity to broaden your skills and experience, whilst playing an integral role in the clinical trials process. We are looking to recruit dedicated and committed individuals with experience of working in a clinical research related environment. The successful candidate will have an interest in specialising in Contracts, Site Identification, Ethics or Core Documents, combined with a degree, or equivalent, in a scientific or healthcare discipline.
PURPOSE
Serve as Site Start-Up (SSU) lead for small project(s) or programs. Lead SSU team by providing operational strategy and parameters for review/negotiation of contracts and regulatory documents. May participate in feasibility and/or site identification activities.
RESPONSIBILITIES
· Serve as Site Start-Up lead within a country or region for projects or service line. Lead SSU team or service line members in all designated activities. Monitor team efficiency and adherence to project timelines. Ensure adherence to standard operating procedures (SOPs) and work instructions (WIs) and quality of designated deliverables.
· Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
· Review and provide feedback to management on site performance metrics.
· Work with sponsors and internal team members to establish regulatory requirements and contracts necessary for startup. Review and negotiate regulatory documents, contracts, and contract amendments with sites and sponsors for agreement on wording and budgets. Ensure accuracy and completeness of documents.
· Serve as central contact for investigative sites, designated project reports, and customer service.
· Resolve site issues and determine status for product shipment.
· Work with regulatory team members or sponsor to secure authorization of regulatory documents.
· Work with legal team members or sponsor to secure authorization of contracts.
· Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.
· Where applicable, provide work instructions to team members in preparation of regulatory submissions.
· May translate or review completed translations of critical documents.
· May participate in feasibility and/or site identification activities.
