Sma Ii

**Site Management Associate II (SMA II)**

**JR112563**

**Site: São Paulo - Brazil**

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.

Clinical Delivery SMAs work only with active sites, from site activation through close out, all maintenance portion - Startup stage is managed by SMAs from SSU.

**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.
- Sets up and maintains site-related data in applicable clinical systems according to procedures and guidelines.
- 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, to ensure successful site activation 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.
- May perform onsite visits as needed
- This position requires to be in charge of site management related activities, be primary contact with the sites for support and doubts regarding the protocols, perform off-site monitoring activities (Site Management Contacts or Off Site Monitoring Visits depending on study model), collecting, reviewing and maintaining sites Ess. Docs, managing the electronic Trial Master File for each site, performing periodic QCs of the eTMF, updating Clinical Management Systems, local regulatory tasks related to protocol amendments submissions packages preparations for sites/ethics committees submissions and related payments process and FUP, ICFs adaptations/review at site level, Ethics Committees annual renewal and progress/annual reports, site & study close out related tasks._

**You will need**:
Desirable experience with the TMF system, or any clinical trial management system

2-3 years. Monitoring/remote monitoring experience recommended.

Advanced English for reading, writing, and speaking.

Spanish is not required but is a plus

Intermediate Excel

Bachelor´s Degree in scientific or health care, preferred.

Must be based in Sao Paulo, and available to attend the office as per projects and business needs.

**_ Note: Hybrid Position_**

**To be successful in the role, you will have**:
**Benefits of Working in ICON**:
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 cultur