Site Specialist II

Site Specialist II - Hybrid Mexico City

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.

Job Description Summary:

Support preparation, process and tracking of regulatory and site level critical documents and of site activation tasks required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable regulations/guidelines and the principles of ICH/GCP. Embrace and contribute to ICON’s culture of quality and process improvement with a focus on enhancing processes, systems and tools, adding value to our business and meeting or exceeding client needs.

- Location: Mexico City (required)

- Hybrid model (3 days in the office – 2 days working from home)

- CVs must be in English

Responsibilities:

• Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.

• Support Site Partners to collect, review, organize and assemble initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.

• Support collection and assembling of all documents needed in the Critical Document Package (CDP) and/or those required for site activation, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable requirements and ICH/GCP guidelines.

• Support coordination of all necessary translations required for any start-up documentation.

• Perform timely and accurate progress data entry of all documents collected from sites and of the relevant study site activation activities into the appropriate tracking systems and tools.

• Participate to internal study review meetings with study teams to provide updates on site progress in document collection and on the executed site activation tasks.

• Accurately forecast Site Activation plans and ensure that they are reflected accurately in ICON’s systems and proactively follow through for achievement to plan.

• Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.

• Attend study team meetings as required

What you need to succeed in the role:

• Bachelor’s Degree preferably in Life Sciences

• Minimum of 2 years’ experience or understanding of clinical study start up requirements and activities.

• Knowledge of local and/or international regulatory processes, including submissions to regulatory authorities and ethics committees.

• Ability to read and understand clinical protocols, regulatory documents, and study-specific processes.

• Strong attention to detail and organizational skills.

• Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.

• Excellent communication skills both in English and Spanish

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply