Site Management Associate (Senior and level I)

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 on our mission to shape the future of clinical development.

What you will bring:

As a Site Management Associate at ICON you will be responsible for managing, implementing and monitoring clinical studies, with support, in a team setting within a global organization.

Following an initial training period, you will begin working on large global projects within a variety of therapeutic areas. The work of a Site Management Associate is varied and challenging whilst offering you the opportunity to use your language skills. As a Site Management Associate at ICON, your responsibilities will include:

• 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 and site level maintenance of the eTMF

• Update Clinical Management Systems, local regulatory tasks protocol amendments submissions packages preparations for sites/ethics committees submissions.

• Conduct remote site monitoring visits and/or targeted on-site visits as needed.

• 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.

• Perform study tracking CTMS

• 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.

• Provide training and mentoring to less experienced team members.

• Act or assist functional team lead in supporting sponsors (may have direct client interaction) clinical budget management, vendor support/management and evaluation of metrics to identify process improvements.

• Contribute to business development activities by participating in proposals and bid defenses.

• Support manager and interface with partner departments to support enhanced project delivery. Also may create and execute risk management strategies for their aspect of project delivery with oversight from functional team leads/functional managers.

Your profile:

• Bachelor´s Degree, preferable in health/sciences

• In-depth knowledge of the drug development process

• +3 years experience in similar position

• Knowledge about ethics committees and MOH submissions for protocols, amendments, investigator brochure and ICFs

• In-depth knowledge and practical utilization of ICH-GCP and applicable regulatory requirements.

• Advanced English level (oral and written) – mandatory

• Monitoring/remote monitoring experience (recommended for level I - mandatory for senior).

• Good leadership skills, advanced critical thinking as well as strong organization, communication, and time management skills

• Level I: office-based role, attending the office 3 times/week (60/40 attendance scheme).

• Senior: homebased available.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

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, colour, 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 or submit a request here (https://careers.iconplc.com/reasonable-accommodations)

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply