Site Activation Specialist

IQVIA; Madrid; Presencial; EUR 48.000 - 70.000; Jornada completa

Descripción de la vacante

IQVIA’s Global Site Activation team seeks a Site Activation Specialist to coordinate feasibility, site activation, and related maintenance activities for clinical studies in Spain. You will work with the Site Activation Manager, PMs, and other departments to ensure regulatory compliance and timely site startup.

You will review regulatory documents, maintain project plans, and support document distribution to sites and sponsors, ensuring accuracy and adherence to SOPs and ICH/GCP.

Formación

• Minimum of 3 years’ prior experience in Clinical Research.
• Experience with ethics committee and regulatory submissions, contract and budget negotiations, start-up activities, and site activation processes.
• Familiarity with Global Site Activation responsibilities and related regulatory requirements (ICH/GCP).
• Ability to work independently while collaborating with team members and sponsors.
• Strong interpersonal, communication, and organizational skills to maintain relationships with coworkers and sponsors.
• Ability to manage multiple projects and timelines simultaneously.
• Knowledge of local regulations, SOPs, and regulatory requirements.

Responsabilidades

• Serve as single point of contact to perform feasibility, site activation and some maintenance activities for assigned studies.
• Review documents for completeness, accuracy, and consistency under guidance of senior staff.
• Prepare site documents and inform team of completion; distribute to sites and project teams.
• Update and maintain internal systems, databases, tracking tools, timelines, and project plans with accurate information.
• Review, track, and follow up approval and execution of regulatory documents and ethics approvals.

Conocimientos

Clinical Research

Ethics Submissions

Regulatory Knowledge

Independent Work

Communication

Multitasking

ICH/GCP Knowledge

Educación

Bachelor's Degree in Life Science

Descripción del empleo

Madrid, Spain

Full time

R1566949

Site Activation Specialist

Global Site Activation

Location: Spain

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 contractual.

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 or related field

• Minimum of 3 years’ prior experience in Clinical Research

• Experience with activities such as submissions to Ethics Committees and Regulatory Authorities, contract and budget negotiations, study start-up activities, and overall site activation processes

• Familiarity with the day-to-day responsibilities within Global Site Activation essential

• Ability to work independently but also collaborate with others

• 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

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.

At IQVIA, we believe that diversity, inclusion, and belonging empower our mission to accelerate innovation for a healthier world. We create a culture of belonging by valuing the perspectives of all talented employees worldwide and providing them with the opportunity to power smarter healthcare for everyone, everywhere. When our talented employees bring their authentic selves and their diverse experiences to work, they enable us to accomplish extraordinary things. Multifaceted thought processes spark innovation. Multi-talented collaboration harnesses innovation to deliver superior outcomes. Likewise, as part of this culture, IQVIA is committed to ensuring effective equality between women and men, integrating it as a strategic principle in its corporate and human resources policies.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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