SMA I
- Bogota, Mexico City, Lima, Benito Juarez
- Clinical Trial Support
- ICON Full Service & Corporate Support
- Office Based
TA Business Partner
- Full Service Division
About the role
Site Management Associate I - (SMA I)
Office Based role (Flex)
- Mexico City, Mexico
- Lima, Perú
- Bogotá, Colombia
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.
Overview:
As a Clinical Delivery SMA you will work only with active sites, from site activation through close out. Provide overall support to study sites and clinical project teams engaged in clinical research studies. Adhere 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).
This is a Regional role so the SMA can be assigned to projects in own country or within LATAM region and US.
Responsibilities:
Complete essential document collection and review throughout the study lifecycle inclusive site activation.
Manage the electronic Trial Master File for each site, performing periodic QCs of the eTMF
Updating Clinical Management Systems, local regulatory tasks protocol amendments submissions packages preparations for sites/ethics committees submissions.
Manage payments process and FUP, ICFs adaptations/review at site level, Ethics Committees annual renewal and progress/annual reports, site & study close out related tasks.
Act 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 and contacts (pre-study, initiation, monitoring and close out visits). Escalate issues and risks as needed.
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.
What you need:
Bachelor´s Degree, preferable in health/sciences
Knowledge ICH/GCP
Advanced English level (oral and written) – mandatory
Monitoring/remote monitoring experience recommended.
Good organization, communication, and time management skills
This is an office-based role, attending the office 3 times/week. (60/40 attendance scheme)
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.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
#LI-ED1
#LI-Hybrid
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
Day in the life
![Man with headphones on looking at a laptop](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/img/5Z6C1pGWd01xPgjadgXIBA/75/5+tips+to+make+a+lasting+impression+in+your+video+interview+2+(1).jpg)
Teaser label
Career ProgressionContent type
BlogsPublish date
05/10/2024
Summary
Although many employers are returning to the office, we’re still seeing a mix of both video and in-person interviews in application processes. Early in 2020, the number of companies using video interv
![A person using a pipette](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/img/IRyQUaMEcUtAqAja-5NuYg/75/shutterstock_115176037.jpg)
Teaser label
Inside ICONContent type
BlogsPublish date
01/26/2023
Summary
The CRO market has seen an unmistakable uplift in demand for its services in recent years. The call for personalised medicine, pricing pressures, and increasing complexity in clinical trials are j
![](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/img/bllKxdySDUxPrgja41Cz1Q/75/People+Technology+(5).png)
Teaser label
Career ProgressionContent type
BlogsPublish date
12/21/2022
Summary
Salary expectations used to be something discussed after an interview process but now it’s something most recruiters typically ask within the first conversation. This is to ascertain if the remune
by
Jamie Kempski
Who we are
Press play to find out more
![](https://attraxcdnprod1-freshed3dgayb7c3.z01.azurefd.net/1481126/e40ce6f4-d08e-41da-9b68-65e34e789e42/2023.17000.2380/Blob/img/full-width-video.jpg?v=2023.15273-main)
Similar jobs at ICON
Salary
Location
Reading, London
Department
Clinical Operations Roles
Location
London
Reading
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
Title: Clinical Support Associate Location: Central London (3 days in the office per week) Sponsor dedicatedICON plc is a world-leading healthcare intelligence and clinical research organisation. Fro
Reference
2024-111516
Expiry date
01/01/0001
Author
Amani YousefAuthor
Amani YousefSalary
Location
Germany
Department
Clinical Operations Roles
Location
Germany
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
The Clinical Trials Assistant (CTA) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure
Reference
2024-111570
Expiry date
01/01/0001
Author
Roxana RoscaAuthor
Roxana RoscaSalary
Location
Poland
Department
Clinical Operations Roles
Location
Poland
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
As a Snr CTA, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2024-111504
Expiry date
01/01/0001
Author
Dagmara DrozdowskaAuthor
Dagmara DrozdowskaSalary
Location
Portugal
Department
Clinical Operations Roles
Location
Portugal
Remote Working
Office Based
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
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
Reference
2024-111528
Expiry date
01/01/0001
Author
Ana Guerra GaraetaAuthor
Ana Guerra GaraetaSalary
Location
Turkey, Ankara
Department
Clinical Monitoring
Location
Ankara
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
office based position in AnkaraAt 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 impr
Reference
JR119083
Expiry date
01/01/0001
Author
Jakob SchonbergerAuthor
Jakob SchonbergerSalary
Location
Poland, Warsaw
Department
Clinical Monitoring
Location
Warsaw
Remote Working
Office Based
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Trial Support
Job Type
Permanent
Description
Position is based in Warsaw. PolandAt 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
Reference
JR119398
Expiry date
01/01/0001
Author
Jakob SchonbergerAuthor
Jakob Schonberger