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ICON Clinical Research SMA I in Bogota, Colombia

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

  • Minimum required experience in similar position 1 year

  • Desirable experience with the TMF system, or any clinical trial management system

  • 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.

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