Job Description
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. Developing professional individual contributor who works under moderate oversight and supervision. Responsible for making recommendations for enhancements in systems and processes to solve problems or improve the effectiveness of job area. Problems faced are general and may require understanding of a broader set of issues but are not complex.
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 feasibility, site ID, 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 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 plans as needed.
Inform team members of completion of feasibility, site ID, regulatory, and contractual documents for individual sites.
Review, track, and follow up the progress, the approval, and execution of documents, questionnaires, CDA/SIF, 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.
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 related field.
Around +3 years of experience in a CRO or pharma company, specialized in import and export activities.
Advanced level of English.
#LI-NRJ
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.
#J-18808-Ljbffr