Sr. Global Study Manager - Infectious Disease/Vaccines Pragmatic Trials - Canada or US Remote

ICON Strategic Solutions; United States; Remote; CAD 90,000 - 150,000; Full time

Benefits offered by this job

Competitive salary

Health benefits

Retirement plan

Life & disability insurance

Wellbeing resources

Career development

Job summary

ICON is a global healthcare intelligence and clinical research organisation seeking a Senior Study Manager to lead or support trials, coordinate trial deliverables, and manage HQ operations. You will oversee vendor interactions, training, recruitment planning, and CTMS/eTMF setup to ensure on-time delivery.

The role requires 7+ years in clinical research, leadership in pharma settings, and strong communication skills. Home-based in US or Canada with a comprehensive rewards program is offered.

Qualifications

• BS/BA/MS/PhD with 7+ years clinical research experience is required.
• Minimum 2 years pharmaceutical experience with leadership responsibilities.
• Strong ability to meet aggressive timelines.
• MS Project experience preferred.
• Excellent Excel and PowerPoint skills required.
• Infectious disease and/or vaccines experience highly preferred.
• Global experience is required.
• Excellent oral and written communication, data management, and project management skills.

Responsibilities

• Serve as operational lead or support for trials, coordinating deliverables.
• Manage HQ operational activities and clinical trial team interfaces.
• Oversee vendor interactions (IVRS, PRO) and site readiness activities.
• Plan investigator meetings, protocol training, and recruitment tracking.
• Ensure CTMS setup, budgeting alignment, and eTMF maintenance.
• Lead risk assessment, monitoring plans and quality control activities.
• Coordinate with external data coordination and data management teams.
• Ensure timely study close-out and study reconciliation.

Skills

Clinical research

Leadership

Timelines

Excel

PowerPoint

Communication

Data management

Project management

Global experience

Home-based

Education

BS/BA/MS/PhD with 7+ years clinical research experience

Tools

MS Project

Excel

PowerPoint

Job description

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)
• 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 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
• Use of EHR / real-world data
• 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.

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.