PURPOSE: The SSO Contracting Specialist is accountable for coordinator, preparation, and execution of clinical study contracts (PI, site, institution, MSA, local vendors, etc., as applicable) in a direct country or extended country group (OPC and satellite countries) in close collaboration with SSO Study Start-Up Managers, SSO Clinical Project Managers and SSO Finance Specialists in compliance with GCP/ICH and regulatory requirements.ACCOUNTABILITIES:
Supports country SSU strategy in close collaboration with the SSO Study Start-Up Team Lead and the SSO Study Start-Up Managers to ensure SSU timelines and deliverables are met according to country commitments.
-Accountable for coordination, preparation and execution of clinical study contracts and amendments (PI, site, institution, MSA, local vendors, etc., as applicable) for assigned projects.-Tracks and oversees contract status including the dispatch and return of contracts.-Negotiates financial & legal conditions, escalates issues as applicable.-Single point of contact for local Legal and ERC (e.g., for patient reimbursement topics)-Develops and standardizes local contract templates (e.g., for EC submission if required by local regulation) and MSAs.-Adheres to financial standards, prevailing legislations, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.Implements innovative and efficient processes which are aligned with company strategy.ACTIVITES AND INTERFACES:-Externally facing role with impact on Principal Investigators and Institutions/Site business offices.KEY PERFORMANCE INDICTATORS:
Performance against study commitments at the country level, especially set-up/delivery of trials per defined contracting timelines and milestones (coordinator, preparation, and execution of clinical study contracts and amendments)
Delivery of study milestones in accordance with prevailing legislations, ICH/GSP, IRB/IEC, Heath Authority and SOP Requirements
REQUIREMENTS:-Bachelor's degree required-2+ years experience working in clinical trial contractsIQVIA 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.comWe are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoeIQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-statusThe potential base pay range for this role, when annualized, is $57,000.00 - $125,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward. Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA contributes to our shared goal of improving human health. Thank you for your interest in growing your career with us.EEO Minorities/Females/Protected Veterans/Disabled
