Regulatory and Start Up Specialist - Switzerland

ph3Job Overview /h3pPerform 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. May also include maintenance activities. /ph3Home Based position requiring German language fluency. /h3h3Essential Functions /h3pUnder 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. /ppEnsure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. /ppPerform start up and site activation activities according to applicable regulations, SOPs and work instructions. /ppDistribute completed documents to sites and internal project team members. /ppPrepare site regulatory documents, reviewing for completeness and accuracy. /ppEnsure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. /ppReview and provide feedback to management on site performance metrics. /ppReview, establish and agree on project planning and project timelines. /ppEnsure monitoring measures are in place and implement contingency plan as needed. /ppInform team members of completion of regulatory and contractual documents for individual sites. /ppReview, 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. /ppProvide local expertise to SAMs and project team during initial and on-going project timeline planning. /ppPerform quality control of documents provided by sites. /ppMay have direct contact with sponsors on specific initiatives. /ph3Qualifications /h3pBachelor’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. /pulliIn-depth knowledge of clinical systems, procedures, and corporate standards. /liliKnowledge and ability to apply GCP/ICH and applicable regulatory guidelines. /liliKnowledge of applicable regulatory requirements, including local regulations, , SOPs and company’s Corporate Standards. /liliUnderstanding of regulated clinical trial environment and knowledge of drug development process. /li /ulpIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at /ppIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. /ppIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. /ppTo get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. /ppEEO Minorities/Females/Protected Veterans/Disabled /p /p #J-18808-Ljbffr