Senior Clinical Site Manager

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.

As a Senior Clinical Site Manager you will be dedicated to one of our global pharmaceutical clients; with whom ICON shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market. Leading by example, you can set the standard of excellence and enjoy a challenging career in our exclusive programs.

What you will be doing:

Site Engagement Deliverables:

• Develop, communicate, and execute Site Engagement Strategy/Plan working closely with the client Clinical Team and key internal stake holders throughout the life cycle of clinical trials
• Support client clinical team in coordinating and executing site engagement activities by understanding the competitive landscape, capturing trial hurdles and using motivational tactics to ensure timely delivery of trials
• Engage, evaluate and develop a global network of high performing sites through coordinated, consistent interactions using multiple communication channels to create awareness of client and its activities thereby increasing their desire to partner with client
• Develop & maintain relationships with site engagement organizations; assist in identification of high performing sites and key opinion leaders that can contribute to client forums, boards and/or discussions
• Interact/train new investigators to work on client clinical trials

Monitoring Deliverables:

• Responsible for all kinds of site visits (e.g. Selection / Initiation / Monitoring / Close-out / Motivational / Support) and sites’ performance regarding set-up, conduct and data collection
• Primary contact for sites regarding study-related issues.
• Responsible for the early engagement with Key Opinion Leaders (KOLs)/ sites / patients organizations and key contact point for these throughout the study.
• Interact/train new investigators to work on client clinical trials.
• Attend key therapeutic trainings/meetings and/or industry trainings.
• Support CPM in management of the study, including but not limited to:
  • Vendor management
  • Training
  • Logistics
  • Selection of sites
  • Maintenance of study tracking
  • Oversight of eTMF
• Close cooperation with the Clinical Project Managers and members of the Clinicial Trial Teams to inform on all aspects of the clincial trial status at site.
• Ensure appropriate engagement and communication with internal stakeholders regarding site visits and related activities.
• Support the development of key study documents including, but not limited to Case Report Form (CRFs), diaries, informed consent/participant information, the study concept and protocols/amendments including presentations and Investigator Meetings or other trial-related meetings.
• Prepare and/or review monitoring tools, e.g. monitoring manual
• Support CRO/vendor selection activities and provide input in development of contract specifications regarding monitoring activities for clinical trials.
• Review and approval of site regulatory packages
• Prepare or review responses to questions from Regulatory Authorities and IRBs/ECs.
• Contributes to updates of clincial program information, e.g., annual safety updates, Investigator’s Brochure, and on query resolution, as needed, etc.
• Depending on trial setting:
• Train appropriate internal and CRO personnel on trial-specific monitoring requirements.
• Track monitoring activities including review of regulatory package status, visit reports, queries (nature and frequency), and ensure timely collection of the data.
• Conduct co-monitoring visits with internal or CRO personnel to ensure quality of trial and initiate corrective actions where appropriate.
• Utilising all applicable Decentralised Clinical Trial (DCT) methods.
• Shares insights, innovation opportunities and patient needs internally to the team, through collaboration with the client innovation/Technology Transformation Implementation (TTI) Teams.
• Such other responsibilities and projects that the Company may assign, e.g., cooperation on SOPs.

In collaboration with CPM/study team, ensure that the study is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner.

You are:

• A SCRA with a minimum of 3+ years of monitoring experience in France
• Excellent verbal and written communication in French and English
• Operate effectively within an international and rapidly changing environment
• Ability to supervise monitoring and related activities in a clinical trial
• Ability to have scientific discussions with Investigators and Site Personnel
• BA/BS Degree required
• Ability to travel domestically

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 (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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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.

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