Full-Time
Senior Study Manager
Infectious Disease/Vaccines, Pragmatic Trials
Icon
10,001+ employees
Global drug and device development services
No salary listed
Company Does Not Provide H1B Sponsorship
Remote in Canada + 1 more
More locations: Blue Bell, PA, USA
Remote
Bachelor's, Master's, PhD
 Biology & Biotech (1) |
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- A Bachelor of Science, Bachelor of Arts, Master of Science, or Doctor of Philosophy degree is required.
- At least 7 years of clinical research experience is required.
- At least 2 years of pharmaceutical experience with demonstrated leadership responsibilities is required.
- The ability to meet aggressive timelines is required.
- Excellent Excel and PowerPoint skills are required.
- Global experience is required.
- Excellent oral communication, including presentation skills, and written communication skills are required.
- Computer and database management skills are required.
- Project management skills are required.
- The position is home-based in the United States or Canada.
- Employment requires the legal right to work in the country where the role is based.
- Direct experience with protocol design for pragmatic trials is required.
- Direct experience with site or site-network selection is required.
- Direct experience with integration with healthcare systems is required.
- Direct experience with informed-consent approaches, including simplified consent and electronic consent, is required.
- Direct experience with electronic health records or real-world data is required.
- Direct experience with endpoint definition, such as hospitalization and utilization, is required.
- Direct experience with central versus site monitoring approaches is required.
- Direct experience with vendor or technology integration is required.
- Direct experience with regulatory interactions or submissions is required.
- Serve as the operational point of contact for trial execution and all trial deliverables.
- Manage headquarters operational activities, including establishing, leading, and managing the Clinical Trial Team.
- Support clinical drug and vaccine supplies planning.
- Manage deployment and interactions with external vendors, including interactive voice response systems and patient-reported outcome vendors.
- Initiate planning for investigator meetings and protocol training.
- Plan and assess protocol ancillary supplies.
- Complete trial setup and maintain the clinical trial management system.
- Schedule, prepare for, and lead the recruitment planning meeting for the Clinical Trial Team.
- Initiate recruitment and retention planning and track enrollment.
- Track study-related details, including specimens and queries.
- Oversee protocol training activities, including investigator meeting and clinical research associate training meetings.
- Ensure appropriate postings to investigative site portals.
- Manage operational deliverables in preparation for site readiness, country allocation, and achievement of recruitment targets.
- Act as the escalation point for study-related operational issues.
- Manage operational details at operational reviews.
- Create and maintain the project schedule and collaborate with the Program Lead.
- Set up and maintain the electronic Trial Master File.
- Ensure alignment of the budget with protocol needs.
- Execute the protocol within the budget.
- Create and maintain ADI logs.
- Develop the Site Monitoring Plan with input from the monitoring excellence group.
- Develop study-related manuals, including administrative binders and laboratory manuals.
- Manage Emergency Unblinding Call Center activities.
- Co-author newsletters with Clinical Supplies.
- Approve vendor contracts, invoice payments, and change orders as necessary.
- Perform end-of-study reconciliation of clinical and ancillary supplies.
- Oversee all headquarters closeout tasks.
- Monitor trial activities on an ongoing basis, including dashboards and tracking.
- Support Clinical Supplies activities as needed to achieve Clinical Trial Team deliverables.
- Interface with External Data Coordination and Data Management.
- Maintain quality control and inspection readiness at all times.
- Perform risk assessment and execute mitigation planning.
- Experience with Microsoft Project is preferred.
- Experience in infectious disease and/or vaccines is highly preferred.
Provides consulting, development, and commercialization services for drugs and medical devices through a global network to help clients accelerate development and bring products to market. A global team of experts in 53 countries offers end-to-end support across strategy, development, regulatory, manufacturing, and market access to reduce time to market, lower costs, and improve quality. The company differentiates itself with its large global presence, clear focus on speed and cost, and extensive experience across therapeutic areas. Its goal is to help clients accelerate the development of life-saving drugs and devices by delivering high-quality information, solutions, and performance.
Company Size
10,001+
Company Stage
IPO
Headquarters
Ireland
Founded
1990
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Simplify's Take
What believers are saying
- ICON's Q2 2026 backlog reached $23.4 billion, up 3.0% sequentially.
- Phase III opportunities formed roughly 50% of Q2 2026 pipeline, improving revenue quality.
- August 2026 refinancing replaced secured debt and released collateral, strengthening balance-sheet flexibility.
What critics are saying
- ICON restated 2023-2025 revenue after finding overstatements and material weaknesses in controls.
- SEC scrutiny and shareholder lawsuits after February 2026 disclosures threaten management distraction through 2027.
- If sponsors distrust ICON's numbers, CRO bids and renewals deteriorate, risking franchise impairment.
What makes Icon unique
- ICON's Orbis platform now embeds Claude across trial planning, enrollment, protocol, and client integration.
- ICON combines 40,200 employees and 55-country delivery with deep clinical development expertise.
- ICON's bookings engine delivered $3.68 billion gross bookings and 1.51x book-to-bill in Q2 2026.
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Benefits
Health Insurance
Paid Vacation
401(k) Retirement Plan
Mental Health Support
Life Insurance
Flexible Work Hours
Growth & Insights and Company News
6 month growth
↑ 29%1 year growth
↑ 31%2 year growth
↑ 31%ICON plc has priced $2.15 billion in senior unsecured notes through its subsidiary, ICON Investments Six Designated Activity Company. The offering comprises three tranches: $500 million of 5.064% notes due 2029, $1.0 billion of 5.421% notes due 2031, and $650 million of 5.995% notes due 2036. The notes will be guaranteed by ICON on a senior unsecured basis. The offering is expected to close on 13 August 2026, subject to customary closing conditions. ICON intends to use proceeds to repay all outstanding borrowings under its bridge facility credit agreement, repay all outstanding senior secured term loans, and redeem its 5.809% Senior Secured Notes due 2027. Upon repayment, collateral securing ICON's revolving credit facility will be automatically released.
ICON Public Limited Company shares rose 33.2% over three months amid strengthening recovery signs in clinical research demand. Request-for-proposal flow increased 22% sequentially in Q2 2026, with Phase III programmes representing about 50% of opportunity volume. Gross bookings reached $3.68 billion, up 24.1% year-over-year, whilst net business wins totalled $3.12 billion. The book-to-bill ratio stood at 1.51X. Backlog grew 3% sequentially to $23.4 billion, improving revenue visibility. However, second-quarter adjusted EBITDA declined 21.7% year-over-year to $327.2 million, whilst adjusted earnings fell to $2.56 per share from $3.52. Higher pass-through revenues supported sales but pressured margins. Analysts expect 2026 revenues to decline 1% and earnings to fall 15.3% year-over-year.
ICON plc, a clinical research organisation, announced that shareholders approved all resolutions at its Annual General Meeting held on 31 July 2026. The resolutions, which were sent to shareholders on 26 June 2026, included the re-election of several board members and the election of new directors. The approved resolutions covered various corporate governance matters, including authorising the company to allot shares, disapply statutory pre-emption rights, and make overseas market purchases of shares. Shareholders also authorised the price range for reissuing treasury shares. Headquartered in Dublin, ICON employed approximately 40,200 people across 99 locations in 55 countries as of 30 June 2026. The company provides clinical development and commercialisation solutions to pharmaceutical, biotechnology, medical device, and public health organisations worldwide.
ICON plc has announced a multi-year collaboration with Anthropic to integrate Claude's AI capabilities throughout the clinical trial lifecycle. The partnership will advance ICON's Orbis platform, developing four production capabilities: site intelligence and study planning, predictive intelligence for enrolment risks, protocol optimisation, and ecosystem integration. ICON will deploy Claude across its organisation through role-based implementations, including Claude Code for developers and Claude Science for scientific teams. The collaboration will strengthen Orbis's intelligence layer, connecting ICON's expertise and data across trials. Chief Executive Officer Barry Balfe stated the partnership aims to accelerate clinical trials by combining ICON's clinical development expertise with Anthropic's frontier AI capabilities, helping sponsors make better decisions and execute studies with greater precision.
ICON to deploy Claude AI across clinical trial lifecycle. Multi-year collaboration will apply Claude's AI capabilities to trial planning, enrollment risk detection, protocol optimization and client integration. July 28, 2026 Associate Editor Editor's Take: From drug formulation to workflow automation, artificial intelligence (AI) is transforming life sciences. ICON is the latest company to expand its adoption of AI. ICON plc has entered a multi-year collaboration with Anthropic to bring Claude's AI capabilities across the clinical trial lifecycle - further advancing ICON's digital innovation and AI strategy, and building on Orbis, ICON's secure, governed, agentic AI platform. Through this collaboration, ICON will work closely with Anthropic's Life Sciences research team to explore and apply technologies with the goal of accelerating innovation across clinical development. Barry Balfe, CEO of ICON plc, said, "We are determined to lead AI acceleration of clinical trials. Working with Anthropic gives us direct access to frontier AI capability and the people who build it. By combining ICON's clinical development expertise, global delivery model and proprietary trial intelligence with Anthropic's frontier AI capabilities, we believe we can help sponsors make better decisions earlier, execute studies with greater precision and ultimately accelerate the delivery of medicines to patients." How Claude will be deployed. With support from Anthropic, ICON will develop four production capabilities within Orbis: * Site intelligence and study planning: powering ICON's OneSearch and OnePlan tools with frontier model reasoning to sharpen site selection and study feasibility. * Orbis predictive intelligence: enabling real-time detection of enrollment risks, trends and operational signals across active studies. * Protocol optimization: applying AI to protocol design and scenario modelling to reduce amendments and accelerate study startup. * Ecosystem integration: integrating ICON's clinical expertise into client systems, allowing them to securely access ICON's insights directly within Claude. ICON will deploy Claude across the organization through a targeted, role-based rollout: Claude Code for developers, Claude for knowledge teams, and Claude Science for scientific and clinical teams for maximum value creation. "AI holds real potential to address long-standing challenges in clinical development and make a measurable difference for patients," said Pip White, Head of Ireland, UK and Northern Europe, Anthropic. "Far too often, the barrier to getting medicines to patients faster is operational, not scientific. Take study enrollment as an example - it's one of the biggest bottlenecks in clinical development and causes delays in up to 80% of trials. This is exactly the kind of operational challenge that ICON's trial-delivery expertise, paired with Claude, is well suited to address." Earlier this year, BMS announced plans to deploy Claude across its research, clinical development, manufacturing, commercial, and corporate functions.