Study Start Up Associate II

ICON; A distancia; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A global healthcare organization is seeking a Study Start Up Associate II to support regulatory submissions for clinical trials. The ideal candidate should have a high school diploma, a Bachelor’s in Life Sciences, and at least 2 years of relevant experience. Responsibilities include managing regulatory documents and timelines while interacting with ethics committees. The role includes competitive salary packages and benefits, ensuring work-life balance and professional growth.

Servicios

Competitive salary packages

Annual bonuses

Health insurance

Retirement plans

Flexible optional benefits

Formación

• A minimum of 2 years’ experience in clinical study start-up activities.
• Proficient project management skills expected.
• Understanding of regulatory guidelines.

Responsabilidades

• Collect and process regulatory documents for study site activation.
• Interact with Ethics Committees and Regulatory Agencies.
• Manage submission timelines and contingency plans.

Conocimientos

Understanding of clinical study start-up requirements

Project management skills

Clinical Trial operations

Educación

High school diploma or local equivalent

Bachelor’s Degree in Life Sciences

Descripción del empleo

Home Based Mexico

ICON plc is a world‑leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role

As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

• Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.
• Competent Authority (CA), Ethics Committee (EC) and Institutional Review Board (IRB) Submissions.
• Collect, review, organize and assemble regulatory 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.
• Interaction with Ethics Committees, Institutional Review Boards and Country Regulatory Agencies (Competent Authorities) to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct (start‑up and maintenance as assigned).
• Forecast submission/approval timelines and ensure they are achieved; provide contingency plans to mitigate impact if forecasted timelines are not reached, and escalate issues as soon as identified.
• Preparation, Submission, Review and Approval of Critical Document Package (CDP).
• Preparation and submission of site‑level critical documents which are part of the Critical Document Package (CDP) to the Central CDP Review Team (CDPRT) and Sponsor.

What you need for Study Start Up Associate II - Regulatory Submissions

• A high school diploma or local equivalent.
• Bachelor’s Degree preferably in Life Sciences.
• Minimum of 2 years’ experience or understanding of clinical study start‑up requirements and activities.
• Experience of Clinical Trial operations and meeting regulatory guidelines.
• Proficient project management skills.

Benefits of Working in ICON

We offer very competitive salary packages with annual bonuses that reflect performance goals. Our health‑related benefits include retirement plans, life assurance, and additional perks. You’ll also benefit from an environment that encourages purposeful work and lasting change.

In addition to your competitive salary, ICON offers a range of additional benefits focused on well‑being and work‑life balance for you and your family.

• Varied annual leave entitlements.
• Health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings.
• Global Employee Assistance Programme, LifeWorks – 24‑hour access to a network of specialized professionals.
• Life assurance.
• Flexible country‑specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more.

At ICON, we are 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 to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON.

If you are a current ICON employee, please apply through the internal job system.