Job Description SummaryJob Overview
Manage and lead activities associated with Feasibility and/or Site Identification for regional and/or country projects and/or programs.
• Manage assigned opportunities/projects/programs for country or gegion and adhere to timelines and budget. Ensure the site list for assigned studies includes an adequate number of appropriate investigators in accordance with the needs of the sponsor and specificataions of the protocol. Collect and analyze country/regional Feasibility and/or Site Identification information to meet timelines of each study. Attend kick off meetigs to understand study requirements include investigator profile, protocol, process speoifics and timelines. Raise questions and make suggestions based on SID SOPs and Work Instructions. Distribute, track, negotiate and review the Condidential Disclosure Agreements (CDAs) for Feasibility and/or Site Identification with input from the study team, management and Legal when appropriate. Distribute, track and review Site Questionaires for Feasibility and/or Site Information Forms or Site Qualification Questionaires for SID . Enusre completenes, site capability and suitability fo rthe study. For SID reivew SIF and/or SQQ vs the guidance document and approve for SSV or select appropriate sites.Manage investigator database entry and quality, ensuring complete investigator and site information is captured and monitor for duplicate entries. Maintain and update company information reporsitories and databases.
• Bachelor's Degree in life sciences, public health, statistics, business or related field. Master’s degree preferred.
• 2 years' relevant experience including demonstrable experience in acting as the main local lead in studies or equivalent combination of education, training and experience.
• In depth knowledge of the drug development processes across all functional areas
• Strong analytical skills and ability to quickly and accurately understand, access, and analyze data from divergent sources to provide an assimilation of data leading to conclusions and recommendations of site tiering
• Excellent computer skills including proficiency in aspects of data analysis and presentation software, Microsoft Word, Excel and databases
• Critical and creative thinking skills and ability to problem solve
• Detail and quality oriented with strong focus on excellence
• Strong interpersonal skills. Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Ability to explain ideas clearly and negotiate when necessary.
• Excellent organization skills and effective presentation skills
• Knowledge and ability to apply GCP / ICH and applicable regulatory guidelines
• Knowledge of clinical research financial parameters and project financial tracking and accounting methods
• Strong written and verbal communication skills including good command of English
• Effective time management skills and ability to manage competing priorities
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
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 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.