Site Activation Specialist

IQVIA; Milano; In loco; EUR 33.000 - 49.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a Site Activation Specialist in Milan to serve as the single point of contact for feasibility, site activation, and select maintenance activities on assigned studies. You will collaborate with the Site Activation Manager, PM team, and other departments to ensure regulatory and contractual completeness.

The role requires a Life Science degree, 2–3 years of clinical research/site activation experience, and proficiency in regulatory submissions.

Competenze

• Bachelor’s Degree in Life Science
• 2-3 years’ prior experience in clinical research / site activation
• Experience of regulatory submissions essential
• Ability to work independently but also collaborate with others
• Leadership skills
• Good interpersonal, communication and organisational skills to establish and maintain effective working relationships with co-workers, managers and sponsors
• Ability to work on multiple projects
• Knowledge of applicable functional/regulatory requirements, including local regulations, SOPs and ICH/ GCP
• Distribute completed documents to sites and internal project team members
• Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information
• 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

Mansioni

• Serve as a Single Point of Contact to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager, Project Management team, and other departments as necessary.
• Review documents for completeness, consistency, and accuracy, under guidance of senior staff and prepare site documents, inform team members of completion of regulatory contracts.
• Distribute completed documents to sites and internal project team member and updating and maintaining internal systems, databases, tracking tools, timelines, and project plans with accurate and complete project specific information.
• Review, track, and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form, and Investigator Pack release documents.

Conoscenze

Leadership skills

Interpersonal communication

Organisational skills

Project management

Team collaboration

Formazione

Bachelor’s Degree in Life Science

Descrizione del lavoro

Work Location: Milan, Italy Please note that attendance at our Milan office is mandatory at least two days per week

Country Site Activation - CSA Work Location: Milan, Italy Please note that attendance at our Milan office is mandatory at least two days per week

Make an impact on patient health!

IQVIA’s Global Site Activation Team of 2000 employees, drives best in class site and customer experience, with industry leading outcomes. We keep the patient at the forefront; ‘Always Impatient for the Patient’ and we excel in our collaboration with our external/internal customers.

IQVIA’s Country Site Activation team are a global network who identify and activate sites to the highest quality to ensure patients on Clinical trials have access to safe and effective medication. We are leaders in innovation and first to new technologies, meaning a vast amount of career development opportunities are available.

Job Overview

As a Site Activation Specialist, you will serve as a Single Point of Contact to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager, Project Management team, and other departments as necessary.

You will review documents for completeness, consistency, and accuracy, under guidance of senior staff and prepare site documents, inform team members of completion of regulatory contracts. Along with distributing completed documents to sites and internal project team member and updating and maintaining internal systems, databases, tracking tools, timelines, and project plans with accurate and complete project specific information.

You will also review, track, and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form, and Investigator Pack release documents.

Requirements And Skills

• Bachelor’s Degree in Life Science
• 2 - 3 years’ prior experience in clinical research / site activation
• Experience of regulatory submissions essential.
• Ability to work independently but also collaborate with others
• Leadership skills
• Good interpersonal, communication and organisational skills to establish and maintain effective working relationships with co-workers, managers and sponsors
• Ability to work on multiple projects
• Knowledge of applicable functional/regulatory requirements, including local regulations, SOPs and ICH/ GCP
• Distribute completed documents to sites and internal project team members.
• Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
• 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.

Join IQVIA and let’s create a healthier world together:

• Exposure across 21 Therapeutic Areas
• Be part of a global team who operate across 141 locations
• Exposure across a variety of studies and projects
• Access to new, innovative technologies
• Work within a collaborative and vibrant environment
• Own your career!

Unleash your potential!

It takes passion to make the extraordinary possible for patients. Our culture of innovation and collaboration enables us to explore new possibilities and help improve health around the world. When you join our diverse, global team, you’ll harness the power of unparalleled data, advanced analytics, cutting-edge technologies, and deep healthcare and scientific expertise to drive healthcare forward.

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 € - 49.400,00 €. 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.