Senior Project Manager
6 days ago
ICON Strategic Solutions is seeking a highly skilled Senior Project Manager to lead our Oncology trials. As a key member of our team, you will be responsible for the successful delivery of clinical trials, ensuring timely and within-budget completion.
Key Responsibilities:- Manage clinical trial teams, including establishing and leading Clinical Trial Teams (CTTs)
- Support clinical supplies planning, including deployment and interactions with external vendors
- Initiate planning for Investigator meetings and protocol training
- Plan and assess protocol ancillary supplies
- Complete trial set-up and maintain SPECTRUM
- Schedule and prepare for Recruitment Planning Meetings for CTTs
- Initiate recruitment/retention planning and enrollment tracking
- Oversee protocol training activities, including IMs and CRAs training meetings
- Ensure appropriate postings to investigative site portals
- Responsible for operational deliverables in preparation for site ready, country allocation, and achievement of recruitment targets
- Point of escalation for study-related operational issues
- Responsible for operational details at Operational Reviews
- Set up and maintain Trial Master File (eTMF)
- Ensure alignment of budget with protocol needs
- Responsible for executing protocol within the budget
- Responsible for creating and maintaining ADI logs
- Develop Site Monitoring Plan (SMP) with input from the monitoring excellence group
- Develop study-related manuals (e.g., administrative binder, lab manuals)
- Manage Emergency Unblinding (EUB) Call Center activities
- Co-author newsletters with CS
- Approve contracts, invoice payments, and change orders for vendors, as necessary
- Responsible for end-of-study reconciliation (clinical & ancillary supplies)
- Oversee all HQ close-out tasks
- Responsible for ongoing monitoring of trial activities, e.g., dashboards, tracking
- Support 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
We are looking for a highly motivated and experienced Senior Project Manager to join our team. If you have a strong background in clinical research and project management, we encourage you to apply.
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