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IQVIA
,
Reading, Berkshire
Regulatory & Start Up Specialist 2
Overview
Job Description
IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward. We are looking to recruit RSU1, RSU2 and Sr RSU Specialists Responsibilities * Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS. * Perform Regulatory, Start-up and Maintenance activities * 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.] * Ensure contracts are fully executed, regulatory documents and approvals are granted, IP Release authorized and specific project deliverables are completed. * Review and provide feedback to management on site performance metrics. * Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure monitoring measures are in place and implement contingency plan as needed. * May contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. * May assist in pre-award activities including bid defenses, proposals and oversights of the scope of work at country level. * May provide input into contract and budget template development. * May act as Local Regulatory, Ethics and Contract Expert and reviewer of ICF. * May participate in feasibility and/or site identification activities. Required knowledge, skills and abilities * Bachelor's Degree in life sciences or a related field and previous experience withinclinical research industry * In-depth knowledge of clinical systems, procedures, and corporate standards. * Effective communication, organizational, and interpersonal skills. * Ability to manage multiple projects. * 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.. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients. Forge a career with greater purpose, make an impact, and never stop learning.