Senior CRA

As a UK, home-based Clinical Site Manager, you will be partnering with a Japanese Pharmaceutical company, contributing toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.

You will act as the primary local company contact for assigned sites for specific trials

These include;

• Develops meaningful site relationships through consistent collaborative communication and engagement.
• May participate in site feasibility and/or pre-trial site assessment visits.
• Attends/participates in investigator meetings as needed.
• May serve as Lead CSM for specific study providing study level oversight and support for CSMs assigned to the study.  This assignment ensure study level information is shared with assigned CSMs and has key role in establishing site monitoring strategy for study.
• Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
• Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
• Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
• Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
• Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
• Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.

Required Qualifications:

• BA/BS degree with ≥5years of UK experience in pharmaceutical related drug development or direct equivalent experience.
• Five years of UK site monitoring and/or site management experience.
• Strong critical thinking and problem solving skills.
• Willingness to travel up to 40%.
• Proficient in speaking and writing English and must be already UK based.

Preferred Qualifications:

• Experience working cross-functionally and in matrix teams
• Experience mentoring more junior site monitors or site managers
• Experience working in early development studies

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 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

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

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.