Country Associate Submissions Representative (Regulatory & Start-Up Specialist)
Homebased
Italy
IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. agile structure, collaborative culture, and deep therapeutic expertise allow us to deliver tailored solutions that help bring innovative treatments to patients faster.
Job Overview
Position requires EU CTR experience for Italy, local language proficiency, and knowledge of national requirements. Certain submission tasks mandate a local address. 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.
Essential Functions
As Regulatory & Start-Up Specialist, you will work and lead complex projects under general supervision, serve as Single Point of Contact in assigned studies for investigative sites, Site Activation Manager, Project Management team, and other departments as necessary.
You will also ensure adherence to standard operating procedures (SOPs), Work Instructions, quality of designated deliverables and project timelines.
You will prepare submission documents and submit to regulatory bodies.
You will perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions, along with distributing completed documents to sites and internal project team members.
You will also prepare site documents and review for completeness and accuracy, along with reviewing, tracking, and following up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form, and Investigator Pack release documents, in line with project timelines.
Coupled with informing team members of completion of feasibility, site ID, regulatory and contractual documents for individual sites, and providing local expertise to SAMs and project team during initial and on-going project timeline planning. Along with performing quality control of documents provided by sites.
You may also act as an SME on specific subjects, mentor junior CSAs, and have a sponsor-facing role.
Qualifications & Skills
B Sc degree in Health Sciences or related field
1 to 3 years' relevant clinical research experience
Experience in EUCTR and CTIS submission procedures, feasibility and Country Inform Consent adaptation for Italy region very beneficial
Experience in Site Contract negotiations with sites in Italy very beneficial
Experience in medical device submissions is beneficial
In-depth knowledge of clinical systems, procedures, and corporate standards
Good communication skills in local language
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
Understanding of regulated clinical trial environment and knowledge of drug development process
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.iqvia.com
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is €33,000.00 - €61,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
