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Job Overview
The role involves managing and executing the site identification process and performing start-up and maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. Responsibilities include preparing and managing site documentation, reviewing and negotiating site documents and contracts with sites and sponsors, maintaining, reviewing, and reporting on site performance metrics, and serving as the primary point of contact for investigative sites. The role also involves tracking the completion of contractual documents for sites, ensuring contracts are fully executed, and establishing project timelines. Tasks are performed at the regional, or country level under moderate to general supervision, and may include maintenance activities.

Essential Functions
•    Under general supervision, serve as the Point of Contact in assigned studies for investigative sites, 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. Perform quality control of documents provided by sites.
•    Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information. Update and maintain timelines and project plans.
•    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 plans as needed.
•    Inform team members of the completion of regulatory, contractual, and other documents for individual sites. Review, track, and follow up on the progress, approval, and execution of documents such as questionnaires, CDAs, 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 ongoing project timeline planning.
•    May have direct contact with sponsors on specific initiatives.
•    - Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.

Qualifications
•    1 year clinical research experience. Equivalent combination of education, training and experience.
•    Possibility to transfer to CRA positions that may involve business trips as needed

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