Site Activation Partner

hace 3 semanas

Desde casa, México ICON A tiempo completo

As a Site Activation Partner (SAP) I you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions.

You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. You will be engaged in a wide range of interesting and challenging tasks including writing ADaM specifications, programing ADaM datasets, programming efficacy outputs, and submission work.

You will be partnering with one of the worlds premier Biopharmaceutical companies. Working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally.

**What you will be doing**:
The Site Activation Partner performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the Sponsor protocol, standard operating procedures (SOPs), guidelines and all applicable regulatory requirements. At the Senior level, will manage and lead all activities listed above and will ensure that all activities meet Sponsor expectations and are delivered in accordance with the contract, trial protocol and applicable SOPs.
- Performs investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites.
- Utilizes the Clinical Trial Management System (the CTMS) to ensure investigator recruitment activities are accurately tracked.
- Performs essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
- Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
- Performs study tracking via the CTMS or Sponsor designated system to ensure that the study files are current, accurate and complete.
- Documents site and Sponsor contact and study interactions in a timely and professional manner.
- Assists with resolution of investigational site/data queries.
- Provides quality review of the informed consent template.
- Follows up with sites for trial invoices and ensures the CTMS is accurately updated to allow the timely processing of Investigator Payments.

**You are**:

- Knowledge of local regulatory authority drug research and development regulations required.
- Clinical trials support or pharmaceutical industry experience required.

**Why ICON?**

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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