Site Management Associate I

hace 4 meses

Buenos Aires, Argentina ICON plc A tiempo completo

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

**Overview**

Provides overall support to study sites and clinical project teams engaged in clinical research studies. Adheres to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g. ICH-Good Clinical. Practice (GCP), Good Pharmacoepidemiology Practice (GPP), and country/region-specific regulations). Acts as primary point of contact for study sites.

**Responsibilities**:

- Completes essential document collection and review throughout the study lifecycle inclusive of site activation. Organizes and maintains site clinical trial master file (TMF) documents.
- Acts as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies and conducting offsite central monitoring visits/contacts (pre-study, initiation, monitoring and close out visits). Escalates issues and risks as needed.
- Ensure timely and complete data entry by site. Perform data review inclusive of site level data review, query resolution, facilitate database closure and freezing procedures as per study plans.
- Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.
- Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study specific processes, local regulatory requirements.
- Performs a variety of routine essential document collection, review, negotiation, and maintenance and close out tasks under general supervision.
- Complete submissions and notifications to regulatory authorities, ethics committee and other bodies.
- Performs and documents clinical data review and query creation, query resolution, offsite central monitoring contacts/visits and site management communications as outlined in the study plans (and/or other processes)
- Sets up and maintains study documentation in applicable systems, e.g., clinical trial management system (CTMS), TMF system, applicable site/sponsor systems according to project protocol, applicable SOPs and project plans.

**You will need**:

- Desirable experience with the TMF system, or any clinical trial management system.
- 2 years of previous experience in similar positions
- Advanced English for reading, writing, and speaking.
- Intermediate Excel skills
- Degree in Health Sciences

**Note: Hybrid Position**

**Benefits of Working in ICON**:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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