Clinical Study Manager

POL-HB-PM

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 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 (As Project Manager/ CTM on global level).  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.

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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

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