New · posted Nov 1
ICON · Pharmaceuticals
Clinical Study Manager
- Blue Bell, PA
- On-site
- Full-time
- Manager
The role
Clinical Study 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 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 need
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.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
What you'll 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
Pay and benefits
ICON didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Rewards & Benefits
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
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Where you'll work
Blue Bell, PAOn-siteOpen in Maps (opens in a new tab)
More jobs in Blue Bell, PAEqual opportunity, accessibility and legal noticesICON's statements, word for word
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
Job intelligence
The context around this role
Live data · November 1, 2026
Salary intelligence
How the pay compares
Manager roles in the US44 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $150,125 | $163,000 | $175,000 |
Comparisons: the base pay employers published on open Clinical Trial Management roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Trial Management
The general path across 69 open Clinical Trial Management roles on Regulatory Jobs, with the titles they carry most. Not ICON's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct8
- Collaboration and leadership8
- Documentation and SOPs7
- GMP and compliance4
- Lab testing and methods2
- Regulatory submissions2
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
Company hiring pulse
ICON on Regulatory Jobs
- 106
- Open roles
- 56
- Distinct roles
- 30
- Locations
By discipline
- Clinical96 91%
- Quality7 7%
- Regulatory3 3%
By level
- Senior & Principal45 42%
- Associate & Specialist43 41%
- Manager15 14%
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Clinical Study Manager at ICON
Open until filled.