Descripción del trabajo
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Perform in-house site selection, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices applicable regulations, SOPs and work instructions for ALL Latin America countries.
Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
Work collaboratively with other functional groups such as Project Management, Regulatory Start-Up (RSU) and Epidemiology.
Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
Escalate quality issues to Clinical Project Manager (CPM), Site Management Lead (SML) and / or line manager.
Execute assigned work efficiently and adhere to project timelines and financial goals
Perform Site Identification for LA and NA.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation.
Perform Ethics and RA submissions, as well as negotiate site contracts for ALL Latin America countries.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Strong written and verbal communication skills in English and Spanish
Good organizational, interpersonal and problem-solving skills