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

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

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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 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

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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