Clinical Trial Manager

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Clinical Trial Manager at ICON, you will manage clinical trial operations activities, supporting your team and stakeholders to deliver high-quality outcomes across our clinical programmes.

This role is primarily accountable for the end to end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, Sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.

For certain studies, the CRM could be responsible for several countries in a cluster.

Responsibilities include, but are not limited to

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT)
• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from
• feasibility and site selection, recruitment, execution and close out.
• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Sponsor policies and procedures, quality standards and adverse event reporting requirements internally and externally.
• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed.
• Performs Quality control visits as required
• Leads local study teams to high performance: trains in the protocol for other local roles, collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs, and COM)
• Responsible for creating and executing a local risk management plan for assigned studies
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies
• Escalates as needed different challenges and issues to TA Head/CRD/CQM and or CTT (as appropriate)
• Identifies and shares best practices across clinical trials, countries, clusters
• Responsible for collaboration with functional outsourcing vendors, investigators, other external
• partners in assigned studies
• Country POC for programmatically outsourced trials for assigned protocols.
• As a customer-facing role, this position will build business relationships and represent MSD with investigators
• Serves local business needs as applicable in his/her country (If delegated can sign contracts and manage budgets).
• Supports local and regional strategy development consistent with long-term corporate needs in conjunction with CRD, TAH and Regional Operations.
• Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed.
• Lead and contribute to initiatives and projects adding value to the business and supporting the strategy

Your Profile

You will have solid clinical trial management experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience

• University degree in medicine, science, or equivalent combination of education & experience
• Demonstrated ability to drive the clinical deliverables of a study
• Subject matter expertise in the designated therapeutic area
• Prior monitoring experience is preferred
• Willingness to travel as required (approximately 30%)

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 to read more about the benefits ICON offers.

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, 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 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.

Are you a current ICON Employee? Please click here to apply