Site Specialist II

ICON; Lima Metropolitana; Híbrido; PEN 60.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual leave entitlements

Health insurance

Retirement planning

Global Employee Assistance Programme

Life assurance

Descripción de la vacante

ICON is seeking a Site Specialist II to independently manage site support activities, acting as a key operational contact for sites and contributing to efficient study start-up and ongoing maintenance.

You will take responsibility for site management and operations, applying your skills to ensure quality and efficiency in regulatory submissions and study start-up activities within a global environment.

Formación

• Bachelor's degree in life sciences, healthcare or a related field, and clinical research experience.
• Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities (local and/or international regulatory processes, including submissions to regulatory authorities and ethics committees).
• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
• Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously, and to collaborate effectively with cross-functional teams in a fast-paced environment.
• Excellent communication skills both in English and Spanish

Responsabilidades

• Coordinating site-level document collection, review, and maintenance, ensuring accuracy and compliance for assigned sites or studies.
• Acting as an operational liaison for site staff on documentation, systems, and process-related questions.
• Maintaining up-to-date site status, metrics, and key milestones in clinical trial management tools.
• Supporting planning and logistics for site meetings, investigator meetings, and monitoring visits.
• Identifying opportunities to streamline site workflows and contributing to process improvement initiatives.
• Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
• Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
• Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
• Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
• Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Conocimientos

Regulatory affairs

Clinical research

Regulatory submissions

Project management

Cross-functional collaboration

English and Spanish communication

Educación

Bachelor's degree in life sciences, healthcare or related field

Herramientas

CTMS

Regulatory databases

Descripción del empleo

Site Specialist II

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Site Specialist II at ICON, you will independently manage a range of site support activities, acting as a key operational contact for sites and contribute to efficient study start-up and maintenance.

You will take responsibility for site management and operations deliverables, applying your skills to ensure quality and efficiency.

Key responsibilities include:

• Coordinating site-level document collection, review, and maintenance, ensuring accuracy and compliance for assigned sites or studies.
• Acting as an operational liaison for site staff on documentation, systems, and process-related questions.
• Maintaining up-to-date site status, metrics, and key milestones in clinical trial management tools.
• Supporting planning and logistics for site meetings, investigator meetings, and monitoring visits.
• Identifying opportunities to streamline site workflows and contributing to process improvement initiatives.

• Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
• Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
• Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence
• Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
• Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Your Profile:

• Bachelor's degree in life sciences, healthcare or a related field, and clinical research experience.
• Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities (local and/or international regulatory processes, including submissions to regulatory authorities and ethics committees)..
• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.
• Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously, and to collaborate effectively with cross-functional teams in a fast-paced environment.
• Excellent communication skills both in English and Spanish

#LI-ED1

#LI-Hybrid

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well‑being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well‑being.
• Life assurance
• Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here