ICON

Senior Study Manager - Infectious Disease/Vaccines (Pragmatic trials) - US/Canada

United States · Remote (restrictions not stated) · Full time

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About the role

Description from the employer’s posting. Check the employer’s page for the current version.

EmployerICON
LocationUnited States
Work styleRemote (restrictions not stated)
Employment typeFull time
Employer posted7 Jul 2026

Senior Study Manager - Infectious Disease/Vaccines (Pragmatic Trials) - US/Canada

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Senior Study Manager

May lead or support a study or studies, depending on size/complexity. As lead, will be responsible for the following:

Operational point of contact for trial execution and all trial deliverables

Manages all HQ Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT) Supports clinical (drug/vaccine) supplies planning

Manages deployment and interactions with external vendors (e.g., IVRS, PRO)

Show full description

Initiates planning for Investigator meeting and protocol training.

Plans and assesses protocol ancillary supplies

Completes trial set-up and maintains CTMS

Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT

Initiates recruitment/retention planning & enrollment tracking • Responsible for tracking study related details (e.g., specimens, queries)

Oversees protocol training activities including IMs and CRAs training meetings

Ensures appropriate postings to investigative site portals

Responsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others)

Point of escalation for study related operational issues

Responsible for operational details at Operational Reviews

Responsible for creating and maintaining project schedule and collaborating with Program Lead

Sets up and maintains Trial Master File (eTMF)

Ensures alignment of budget with protocol needs

Responsible for executing protocol within the budget

Responsible for creating and maintaining ADI logs

Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group

Develops study related manuals (e.g., administrative binder, lab manuals)

Manages Emergency Unblinding (EUB) Call Center activities

Co-authors newsletters with CS

Approves contracts, invoice payments and change orders for vendors, as necessary

Responsible for end of study reconciliation (clinical & ancillary supplies)

Oversees all HQ close-out tasks

Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking

Supports CS activities as needed to achieve CTT deliverables

Interface with External Data Coordination and Data Management

Responsible for quality control and inspection readiness at all times

Responsible for risk assessment, mitigation planning and execution

What you need to have:

BS/BA/MS/PhD with 7+ yrs clinical research experience Minimum Years of Experience

Minimum 2 years pharmaceutical experience with demonstrated leadership responsibilities required.

Proven ability to meet aggressive timelines

MS Project experience preferred

Excellent Excel and PP skills required

TA- Infectious disease and/or vaccines experience highly preferred

Global experience required

Excellent oral (including presentation) and written communication, computer/database management, and project management skills required

Home Based position in US or Canada

Areas of direct experience:

Protocol design for pragmatic trials

Site/site network selection

Integration with healthcare systems

Informed consent approaches (simplified, eConsent, etc.)

Use of EHR / real-world data

Endpoint definition (e.g., hospitalization, utilization)

Central vs site monitoring approaches

Vendor/technology integration

Regulatory interactions / submissions

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

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