Site Management Associate I

"At ICON, it's our People that set us Apart"

ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 83 locations in 38 countries and has approximately 10,600 employees. Further information is available at www.iconplc.com

Position title : Site Management Associate(SMA)

Role Summary

 The Site Management Associate II (SMA II) is responsible for managing, implementing and monitoring clinical studies, with support, in a team setting according to ICON SOPs, SSPs and all applicable rules and regulations. 

The responsibilities of this position include, but are not limited to: identifying, training/initiating and closing out study sites; conducting remote site monitoring visits and/or targeted on-site visits as needed, conducting remote site management activities, managing study sites and the required protocols, amendments and/or deviations, assuring that data is reported accurately and timelines are maintained. 

Additional Responsibilities:

·      Serves as the primary contact for sites and investigators participating in studies

·      Acts as a resource for internal study teams and other ICON departments

·      Maintains, reviews, and ensures adequacy of information and data contained in site management reports, tracking systems (CTMS or others) and other site management documents

·      Conducts and completes remote site management activities, with support as needed, according to applicable SOPs and the Site Management Plan

·      Supports the Research Services Department by applying critical thinking about the business needs of a study and/or Site Management activities

·      Participates in QA audits as needed

·      Regularly attends and contributes to project specific and departmental meetings

·      Ability and willingness to travel as needed (drive and fly) – approximately 25% of the time

·      Reviews drug storage and drug accountability procedures (as applicable), in accordance with applicable SOPs

·      Maintains and archives study documentation and correspondence, as needed

·      Assists with site contracting process, as needed

·      Assists with timely preparation and submission of regulatory documents for IRB/IEC submissions according to local requirements, with support, as needed

·      Assists with SAB/Steering Committee organization and attendance when applicable

·      Demonstrates increasing ability to manage site assignments and workload

·      Maintains Sponsor and patient confidentiality

·      Actively participates in regular meetings with Project Managers or delegate, and/or RS Lead to discuss project strengths and challenges associated with recruitment, enrolment, site communications and site responsiveness

·      Assumes additional responsibilities as detailed and documented by PM or delegate, RS Lead or Line Management

·      Assists in development of site and patient enrolment strategies with project team; works to motivate sites to meet enrolment timelines

·      Demonstrates ability to implement the study monitoring plans/metrics as appropriate and agreed upon

·      Working knowledge of and compliance with local regulatory requirements

·      Compliant and current with departmental and corporate policies and procedures

 Experience and Qualification

·      Prior relevant site monitoring experience preferred.

·      Experience in a health care and/or research environment.

·      Ability to review and evaluate clinical data.

·      Proficient computer literacy.

·      Good oral and written communication skills for local language and English

·      Preferably with a degree in Life Sciences, you will have previous submissions/dossier experience within clinical studies for either a CRO or Pharmaceutical company.

Benefits of Working in ICON

Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   

What’s Next?

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.