SMA I – ICON

Titulo da Vaga: SMA I

Nome da Empresa: ICON

Salário:

Localização: São Paulo – SP

Descrição da Vaga: Site Management Associate I – (SMA I)Office Based role (Flex)

• Sao Paulo, Brazil

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.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 , 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 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. 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 of site activation.Organize and maintain 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). Escalate 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.Perform risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.Performs a variety of routine essential document collection, review, negotiation, maintenance and close out tasks under general supervisionComplete submissions and notifications to ethics committee and other bodiesPerforms 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).Set 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.What you need:Bachelor´s Degree, preferable in health/sciencesMinimum required experience in similar position 1 yearDesirable experience with the TMF system, or any clinical trial management systemLanguages: Portuguese (Native) /Advanced English level (oral and written) – mandatory / Spanish: not mandatory but useful/encouragedMonitoring/remote monitoring experience recommended.Good organization, communication, and time management skillsThis is an office-based role, attending the office 3 times/week. (60/40 attendance scheme). Candidate must be located in Sao Paulo.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-HybridAre you a current ICON Employee? Please click here to apply:

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