Study Start Up Support (Europe, Homebased) - IQVIA Biotech
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.
• 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.
• Bachelor's Degree B.A./B.S. preferably in a business or science/health care field, nursing degree, or equivalent degree
• One year of prior experience in a client service role at a biotechnology or pharmaceutical company, CRO, or other organization supporting clinical research or healthcare activities. Basic knowledge of the clinical trial process.
• Analytical Thinking: Tackle problems by using a logical, systematic, sequential approach
• Attention to Communication: The ability to ensure that information is passed on to others who should be kept informed
• Fostering Teamwork: The ability and desire to work cooperatively with others on a team
• Customer Orientation: The ability to demonstrate concern for satisfying one’s external and/or internal customers
• Initiative: Identifying what needs to be done and doing it before being asked or before the situation requires it
• Oral Communication: The ability to express oneself clearly in conversations and interactions with others
• Thoroughness: Ensuring that one’s own and others’ work and information are complete and accurate
• Written Communication: The ability to express oneself clearly in business writing
• Supervisory Responsibilities
This position does not have responsibility for managing people.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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