Site Management Associate II

ICON San Antonio; Ciudad de México; Ibrido; MXN 300.000 - 420.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual leave

Health insurance

Retirement plan

LifeWorks EAP

Life insurance

Flexible benefits

Descrizione del lavoro

ICON Strategic Solutions is seeking a SMA II to support management and monitoring of clinical trial sites, ensuring GCP compliance and regulatory adherence. The role emphasizes non-site-facing administrative support and TMF oversight within a sponsor-dedicated model.

The position starts office-based for four months, then transitions to a hybrid model with three days in the office and two days remote. A strong clinical research background and TMF/CTMS experience are highly valued.

Competenze

• Bachelor’s degree in Life Sciences or related field.
• 2+ years of clinical research experience.
• CTA responsibilities and TMF management exposure.
• Experience supporting global trials across regions.
• Strong knowledge of GCP and regulatory requirements.
• Excellent organizational and communication skills.
• Experience with eTMF, CTMS, and MS Office preferred.

Mansioni

• Provide advanced administrative and operational support across study start-up, maintenance, and close-out.
• Support TMF documentation and inspection readiness.
• Assist with site activation and regulatory document tracking.
• Coordinate communication among internal teams, sites, and vendors.
• Track study progress, metrics, and deliverables; identify risks.
• Support contract and budget tracking activities.
• Mentor junior CTAs or administrative staff.

Conoscenze

Organizational skills

Communication skills

Problem solving

Time management

Teamwork

Formazione

Bachelors in Life Sciences

Strumenti

eTMF

CTMS

Microsoft Office

Descrizione del lavoro

MEXICO CITY. OFFICE BASED.

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a SMA II at ICON, you will support the management and monitor of clinical trial sites by ensuring compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.

What You Will Do

You will contribute to clinical research activities, taking ownership of key CTA deliverables while collaborating closely with cross-functional teams.

Key Responsibilities Include

• Providing advanced administrative and operational support to clinical trial teams across study start-up, maintenance, and close-out activities.
• This is a non site-facing role. The position focuses on clinical trial administrative and operational support and does not involve direct on-site monitoring or routine in-person interaction with clinical sites.
• Managing and maintaining Trial Master File (TMF) documentation, ensuring completeness, accuracy, and inspection readiness in compliance with GCP and regulatory requirements.
• Supporting site activation activities, including collection, review, and tracking of essential regulatory documents.
• Acting as a key point of contact for internal stakeholders, sites, and vendors to ensure effective communication and coordination throughout the study lifecycle.
• Tracking study progress, site metrics, and deliverables, proactively identifying risks or delays and supporting resolution.
• Coordinating study-related logistics such as investigator payments, supplies, and document workflows.
• Assisting with audit and inspection readiness activities, ensuring documentation is complete and compliant.
• Supporting contract and budget tracking activities in collaboration with relevant teams.
• Mentoring or providing guidance to junior CTAs or administrative staff, as applicable.

Your Profile

You will bring solid clinical research experience with a strong focus on clinical trial administration, along with the following qualifications and skills.

Required Qualifications And Experience

• Bachelor’s degree in Life Sciences, Healthcare Administration, Clinical Research, or a related field.
• 2+ years of experience in clinical research, with strong exposure to CTA responsibilities and TMF management.
• Experience supporting global clinical trials and collaborating with cross-functional teams across multiple countries and regions.
• Solid understanding of clinical trial processes, including study start-up, regulatory documentation, and site support activities.
• Strong knowledge of GCP guidelines and applicable regulatory requirements.
• Excellent organizational and time management skills, with the ability to manage multiple priorities in a fast-paced environment.
• High attention to detail and strong documentation skills.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders.
• Proactive mindset with strong problem-solving and risk identification capabilities.
• Experience with clinical systems (e.g., eTMF, CTMS) and Microsoft Office tools is preferred.

Work Model

• This role is office-based during the first four months to support onboarding, training, and team integration.
• Following the initial onboarding period, the role will transition to a hybrid work model, with 3 days in the office and 2 days working from home each week.

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.

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

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