Study Associate II

hace 3 semanas


Xico, México Icon A tiempo completo

As a Study Associate II at ICON, you will play a key role in accelerating the development of our customers' drugs and devices through innovative solutions. You will be dedicated to one of our clients, embedded in their working environment, systems, and processes. Your tasks will include writing ADaM specifications, programming ADaM datasets, and submission work.

**Key Responsibilities:**

Performs investigator recruitment activities using phone scripts, questionnaires, and study site materials.

Utilizes the Clinical Trial Management System (CTMS) to track investigator recruitment activities.

Collects, reviews, maintains, and closes out essential documents, ensuring sponsor and investigator obligations are met and compliant with local regulatory requirements and ICH/GCP guidelines.

Supports investigators and investigative staff in fulfilling obligations regarding local submissions.

Performs study tracking via the CTMS or Sponsor designated system to ensure study files are current, accurate, and complete.

**Requirements:**

Knowledge of local regulatory authority drug research and development regulations.

Clinical trials support or pharmaceutical industry experience.

Advanced English language skills.

**Why ICON?**

At ICON, we value diversity and inclusion, and we are committed to providing a workplace free of discrimination and harassment. We offer a comprehensive total reward package, including competitive base pay, variable pay, and recognition programs, as well as best-in-class employee benefits and wellbeing initiatives.


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