Sr Site Activation Specialist

IQVIA Argentina; Madrid; Presencial; EUR 52.000 - 70.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Exposure across 21 Therapeutic Areas

Global team across 141 locations

Access to new, innovative technologies

Collaborative and vibrant environment

Own your career!

Descripción de la vacante

IQVIA's Global Site Activation team in Spain seeks a Senior Site Activation Specialist to lead complex projects and serve as a single point of contact for investigative sites and project teams. You will ensure SOPs and timelines are followed, perform feasibility, site ID, start-up, and activation activities, and review documents for completeness and accuracy.

You may mentor junior CSAs and act as SME on key regulatory subjects.

Formación

• Bachelor’s degree in Life Sciences or related field.
• 3–4 years’ experience in Clinical Research, including 1 year in a leadership capacity.
• Experience with submissions to Ethics Committees and Regulatory Authorities, contract and budget negotiations, study start-up activities, and site activation processes.
• Knowledge of applicable functional/regulatory requirements, including local regulations, SOPs and ICH/GCP.
• Strong negotiation and communication skills and ability to manage multiple projects.

Responsabilidades

• Perform feasibility, site ID, start-up and site activation activities according to SOPs and work instructions.
• Distribute completed documents to sites and internal project team members.
• Prepare site documents and review for completeness and accuracy, track progress and approvals.
• Review, track and follow up on regulatory, ethics, CDA/SIF and Investigator Pack release documents.
• Provide local expertise to SAMs and project teams during project planning and execution.
• Act as SME on specific subjects and mentor junior CSAs; sponsor-facing role.

Conocimientos

Leadership

Communication

Problem solving

Multi-project management

Regulatory knowledge

Educación

Bachelor’s Degree in Life Sciences or related field

Descripción del empleo

Senior Site Activation Specialist

Global Site Activation

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 Senior Site Activation 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 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.

Requirements:

• Bachelor’s Degree in Life Sciences or related field
• Minimum 3 - 4 years’ prior experience in Clinical Research, including 1 year in a leadership capacity.
• 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
• Strong problem solving skills
• Ability to negotiate and have strong communication skills
• 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.