Clinical Study Manager

Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget • Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned study • Ensures alignment of regional deliverables with overall study goals.

Regional Leadership • Leads the regional clinical operations team effectively, ensures effective decision making and acts as point of escalation for resolution of issues within the region for the assigned study • Leads external vendors involved in study delivery on a regional level • Collaborates with key stakeholders in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required • Represents the regional study team at internal meetings and at the cross-functional Clinical Study Team (CST) meetings • Leads regional operations meetings with all regional study team members Timelines, Planning and Execution • Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for region, in line with global study timelines • Generates, manages, and maintains high quality study start up and recruitment timelines for region and tracks progress towards these • Ensures that the clinical study is operationally feasible in the region, drives trial feasibility, country allocation and site selection process for assigned region in collaboration with feasibility managers, country heads, medical affairs and any other stakeholders • Provides regional input on global study plans as required • Ensures timely availability of local adaptations of global study documents such as informed consent forms, in close collaboration with other key stake holders to ensure timely submission to regulatory authorities and ECs/IRBs • Accountable for submissions of study in countries in assigned region in close collaboration with regional study start up team and regulatory affairs • Ensures regional and country information in study systems and tools is entered and up to date • Collaborates closely with CRAs in the region to ensure proper study execution at the sites.

4 or more years of progressive experience in clinical research within biotech, pharma or CRO industry • Proven experience in clinical research including relevant experience as team lead in clinical functions • Experience as CRA is preferred Travel: Travel might be required as per business need.

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, inclusion & belonging are fundamental to our culture and values. 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, 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 through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the require

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.

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