Clinical Study Manager

ICON Strategic Solutions; United States; On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee assistance program LifeWorks

Life assurance

Flexible country-specific benefits

Job summary

ICON Strategic Solutions is seeking a Project Manager / FSP Clinical Study Manager dedicated to a single sponsor to lead and coordinate global trial activities. You will ensure on-time, on-budget delivery to high-quality standards across studies.

Responsibilities include overseeing CRO/vendors, ensuring regulatory compliance, and maintaining inspection readiness. Strong leadership, communication, and GMP/ICH GCP knowledge are required.

Qualifications

• 5+ years in pharmaceutical industry and/or CRO.
• 3+ years of clinical study management oversight.
• Experience in early phase or Phase 2/3 studies and global/international programs.
• Experience in more than one therapeutic area is advantageous.

Responsibilities

• Support the execution of studies in compliance with ICH GCP, local regulations, and SOPs, on schedule and on budget.
• Plan and operationally execute tasks within trials; coordinate with functional leads to meet milestones and objectives.
• Oversee CRO/vendor selection, budget/contract negotiations, and supervision of performance; escalate issues to governance as needed.
• Ensure studies are inspection-ready and participate in regulatory inspections when required.
• Prepare for agency inspections, maintain document readiness, and support CSR writing and review.
• Collect/review TMF and regulatory filing documents to support trial activities.

Skills

Project management

Vendor management

Leadership

Communication

Global regulatory knowledge

PMP/PRINCE2

CTMS

Travel readiness

English fluency

Tools

CTMS

Job description

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise. As the world's largest FSP organization, 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 Project Manager at ICON, working as an FSP Clinical Study Manager, exclusively dedicated to one pharmaceutical company, you will be responsible for leading and coordinating project activities, ensuring that global trials are delivered on time, within budget, and to the highest quality standards.

What You Will Do

Your focus will be on supporting aspects of operational delivery, working in close collaboration with the Global Trial Study Leader.

Key Responsibilities May Include

• Supporting the execution of select studies in compliance with quality standards (including ICH GCP, local regulations and SOPs), on schedule and on budget.
• Accountable for planning and operational execution for specific tasks within assigned clinical trials. Coordinating with functional leads, ensuring milestone delivery and project objectives are met.
• Oversight of Strategic Partners - CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a Strategic Partner for assigned studies, including escalation of issues to governance committees when warranted.
  • Specific areas of sponsor oversight include, but are not limited to:
  • Review and approval of key monitoring documents/plans, periodic review of outputs, decisions and actions related to monitoring
  • Conduct Oversight Monitoring Visits, as applicable
  • Review and endorsement of relevant study plans, as applicable
  • Study team meeting management and attendance when necessary; regular review of meeting agendas and minutes
  • Review of outcomes/actions related to protocol deviations review; primary purpose of review is to support the identification of trends across sites and/or the study
  • Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies
  • Review and ownership of trial operational data (e.g. CTMS)
  • Review and provide oversight of internal trial reports
• Ensure studies are "inspection ready" at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.
• Preparation for Agency inspections, including document readiness, tracking, storyboard development and other pertinent documents and preparations.
• Support data review for database lock and CSR writing and review (including appendices).
• Collect/review/File study documents in support of the trial master file (TMF).
• Collect/review/File study documents in support of the regulatory filing.

Your Profile

Required qualifications and experience:

You will have 5+ years' experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management oversight, including significant study management support experience (e.g. clinical trial assistant/associate or lead CRA). Experience could include either early phase clinical studies or Phase 2 and 3 studies and global/international studies or programs. Experience in more than one therapeutic area is advantageous.

• Proven track record of successfully managing projects, with a focus on delivering results within scope, time, and budget constraints.
• Experienced in vendor selection and oversight
• Strong leadership and organizational skills, with the ability to effectively manage project teams and prioritize tasks.
• Excellent communication and interpersonal skills, with the ability to build relationships and manage stakeholder expectations.
• Knowledge in global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, and ICH GCP. Awareness of local country requirements may also be required.
• Proficiency in project management tools and methodologies, with certifications such as PMP or PRINCE2 being advantageous.
• Detail-oriented, proactive, and adaptable, with a commitment to achieving project goals and driving continuous improvement.
• Fluent business English (oral and written)
• Travel Requirements are minimal. The opportunity for travel to support a key trial meeting may occasionally arise.

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