SMA II

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.

The Role:

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.

To be successful in the role, you will have:

• 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.

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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