About this role
About the Role Senior Study Manager leads or supports pragmatic infectious disease/vaccines trials and serves as the operational lead for trial execution. You’ll coordinate Clinical Trial Team activities, vendor interactions, recruitment and site readiness, and ensure delivery of trial objectives within budget and regulatory requirements. What You'll Do
- Serve as operational point of contact for trial execution and all trial deliverables.
- Lead and manage HQ Operational Activities, including establishing and guiding the Clinical Trial Team (CTT).
- Manage clinical supplies planning and oversee external vendors (e.g., IVRS, PRO).
- Initiate planning for Investigator meetings and protocol training; maintain CTMS and prepare for Recruitment Planning Meetings.
- Plan and track recruitment/retention and enrollment; monitor specimens and queries.
- Oversee protocol training activities (Independ ent Monitors, CRAs training) and ensure postings to investigative site portals.
- Ensure operational deliverables for site readiness, country allocation, and recruitment targets; act as escalation point for operational issues.
- Create and maintain project schedule, eTMF, ADI logs, and Site Monitoring Plan; develop study manuals.
- Co-author CS newsletters and approve contracts, invoices, and change orders for vendors.
- Oversee end-of-study reconciliation and HQ close-out tasks; monitor trial activities via dashboards.
- Interface with External Data Coordination and Data Management; ensure quality control and inspection readiness; assess risk and execute mitigation. What We're Looking For
- BS/BA/MS/PhD with 7+ years of clinical research experience; minimum 2 years pharma experience with leadership responsibilities.
- Proficiency with MS Project; advanced Excel and PowerPoint required.
- Infectious disease and/or vaccines experience highly preferred; global experience required.
- Excellent oral and written communication, plus strong computer/database and project management skills.
- Home-based position in the US or Canada. Nice to Have
- Experience in protocol design for pragmatic trials; site/network selection; EHR/real-world data integration; eConsent approaches; endpoint definition; central vs site monitoring; regulatory interactions/submissions; vendor/technology integration. Compensation & Benefits
- Competitive salary and benefits designed to support well-being and work-life balance, including annual leave, health insurance, retirement planning, LifeWorks EAP, life assurance, and flexible country-specific benefits.
- Access to global support networks and professional development opportunities.