REGULATORY AND START UP SPECIALIST (FSP) PORTUGAL

Job Overview 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.
Fluent in Portuguese and English.
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 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.
Qualifications Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
Effective communication, organizational, and interpersonal skills.
Ability to work independently and to effectively prioritize tasks.
Ability to manage multiple projects.
Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
Knowledge of applicable regulatory requirements, including local regulations,, SOPs and company’s Corporate Standards.
Understanding of regulated clinical trial environment and knowledge of drug development process.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
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.
qvia.
om IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward.
Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities.
No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health.
Thank you for your interest in growing your career with us.