Sma I or Sma Ii

SMA I or SMA II - Hybrid - São Paulo or Buenos Aires

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

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre 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.

About the role

As Site Management Associate (SMA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.

You will be embedded in working environment, systems and processes. You will be engaged in a wide range of interesting and challenging tasks.

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:
- 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.-
- Performs a variety of routine essential document collection, review, negotiation, to ensure successful maintenance and close out tasks under general supervision.-
- In partnership with the study team, manages recruitment of study sites, ensuring activities, documents and all other clinical data are accurately tracked and documented for the project lifecycle. Escalates issues as needed to mitigate recruitment risks.-
- Completes 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).-
- May conduct data review at a project level or region level.-
- 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 to ensure sponsor and investigator obligations are being met and are compliant with applicable regulatory requirements and guidelines-
- Provides team leadership, training and assessment/coaching feedback to site management team members. Assists management with the development of process documents and training materials.-
- Assists project team with the development of process documents as needed.What do you need:

- Complete Bachelor’s Degree (Health Science)
- 2 years + experience working with Global Teams as an IHCRA, Study Coordinator or related areas
- Mandatory Fluent English Skills (Communication, Reading, Writing)
- Knowledge/experience on systems is relevant (VEEVA and others)
- Availability to work Office Based Moema / São Paulo or Villa Adelina, Partido San Isidro - Buenos Aires

LI-Onsite

LI-AR2

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 culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At 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.

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

What ICON can offer you