Senior Study Manager - Infectious Disease/Vaccines (Pragmatic Trials) - US/Canada
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
Rewards & BenefitsICON 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.
