Fantastic opportunity to embed yourself in our global clinical operations team working asStudy Start-up Specialist in Portugal
Become an SSU expert managing and performing all tasks at country level associated with Regulatory, Start-Up and Maintenance. Develop your experience working with different sponsors across a multitude of therapy areas and phases.
Your responsibilities might include:
Serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Feasibility, Site Identification and Project Leadership.
Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
Review, prepare and negotiate site contracts and budgets with sites.
Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics ICF and IP Release documents, in line with project timelines.
Prepare site regulatory documents, reviewing for completeness and accuracy.
Distribute completed documents to sites and internal project team member
Review and provide feedback to management on site performance metrics.
Review, establish and agree on project planning and project timelines. Ensure overall project efficiency and adherence to project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
Where applicable, act as a Country Lead for projects and assist in pre-award activities including bid defenses, proposals and oversights of the scope of work at country level.
May act as Local Regulatory, Ethics and Contract Expert and reviewer of ICF.
May act as mentor, and prepare and deliver country-specific training, for less experienced staff.
Skills & Requirements
A Bachelor's degree in a health care or other scientific discipline or educational equivalent
+2 years of experience in the submission of applications, modifications and notifications of Clinical Trials to the Health Authorities (AEMPS) and site contract negotiation.
Fluency in Portuguese & English
Effective communication, organizational and planning skills
Ability to work independently and to effectively prioritize tasks
Ability to work on multiple projects
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Good command of English
We invite you to join IQVIA™
Recognized by Great Place to Work as the second best company to work for in Spain (March 2019)
FORTUNE Magazine's World's Most Admired Companies list for the fourth year in a row (January 2021)
Recognized by the 2016 Scrip Awards as the Best Full-service Provider Contract Research Organization (CRO)
Awarded the 2016 Eagle Award from the Society for Clinical Research Sites (SCRS) for the fourth consecutive year.
A site-nominated award recognizing contract research organizations (CRO) and biopharmaceutical sponsors dedicated to building positive relationships with research sites through leadership, professionalism and integrity .
IQVIA™ named in The International Association of Outsourcing Professionals (IAOP) 2017 Global Outsourcing 100® List which recognizes the world’s best service providers across a range of industries.
IQVIA™ is an equal opportunity employer . We make employment decisions based on qualifications and merit. We prohibit discrimination based on any unlawful consideration such as age, race, national origin, gender or other "protected status.“
We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us . You will have the opportunity to play an important part in helping our clients drive healthcare forward and whatever your career goals, we are here to ensure you get there!
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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