Manager, Study Management

Manager, Clinical Operations

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 Do:

• Manage integration of project team activities, leveraging internal and external resources, expertise and knowledge, along with optimizing CRO resources, expertise and knowledge.

• Provide input on trial level operational strategies for clinical trials from protocol design to the final clinical study report for specified studies

• Provide input into global subject/patient recruitment plans.

• Relationship management between study sites and vendors

• Manage aspects of CRO/vendor identification and the day to day operational management activities of CROs & other vendors including set up, statement of work creation and budget oversight.

• Manage strategic study operations including:  study sites and tracking systems for regulatory submissions, drug supply and use, enrollment of subjects, regulatory document flow, study timelines, all budgetary and financial information, performance metrics, data flow, etc.

• Create and update critical trial-specific documents (for example country specific ICF) and plans

• Support development of compound and protocol level training materials

• Review and provide input into budgets, timelines, and forecasts for assigned clinical studies

• Interface with internal key stakeholders including, but not limited to; Finance, Program Management, Vendor Management, Safety, Accounting, Clinical Supply, Quality Assurance, Data Management, Statistics, Clinical Research, Commercial, Regulatory, Bio Analytical, Medical Affairs; which may include acting as a liaison between groups.

• Provide support for inspection readiness activities and on identification of risks and mitigation plans at the trial level

• Participate in process improvement activities at a trial and department level as needed

Your Profile:

• BS/ BA Degree is required.

• 5+ years of clinical research experience gained with a CRO, Biotech, or Pharmaceutical Company working on Phase 1-4 global clinical trials. 

• 2-3+ years leading aspects of global clinical trials

• Experience working with a CRO

• Strong regulatory knowledge, including Good Clinical Practices (GCPs)

• Strong decision-making, analytical and financial management skills are essential to this position

• Proven ability to foster team productivity and cohesiveness and the ability to operate and execute with limited supervision

• Experience in leading without authority and in multifunctional matrixed and global environments

• Experience mentoring/ coaching others

• Exceptional organizational skills and ability to deal with competing priorities, also strong reasoning and problem-solving ability.

• Strong project planning/ management, communication (written and verbal) and presentation skills

• Experience with protocol, ICF, CRF, CSR development and review.

• Proficient with MS Office Suite (Excel, Word and PowerPoint)

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