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Full-time
bachelor degree
Posted 1d ago
~40 hrs/week
Remote in Basel, Basel-City, Switzerland
Responsibilities
The Regulatory and Start Up Specialist serves as the primary point of contact for site activation activities, ensuring adherence to regulatory standards and project timelines. They are responsible for preparing and reviewing regulatory documents, maintaining internal databases, and coordinating with project teams to ensure site readiness.
Requirements
Candidates must hold a Bachelor’s degree in life sciences or a related field and possess at least 3 years of relevant clinical research experience. Proficiency in German is required, along with a strong understanding of GCP/ICH guidelines and the drug development process.
Full job 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. May also include maintenance activities.
Home Based position requiring German language fluency.
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 on-going 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.
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.
IQVIA 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 https://jobs.iqvia.com
IQVIA 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.
IQVIA (NYSE:IQV) is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. IQVIA’s portfolio of solutions are powered by IQVIA Connected Intelligence™ to deliver actionable insights and services built on high-quality health data, Healthcare-grade AI™, advanced analytics, the latest technologies and extensive domain expertise. With approximately 88,000 employees in over 100 countries, including experts in healthcare, life sciences, data science, technology and operational excellence, IQVIA is dedicated to accelerating the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific progress, in an effort to advance healthcare. To learn more, visit www.iqvia.com.
Offices: 2400 Ellis Rd, Durham, North Carolina 27703, US