ICON is looking for a Senior Project Manager with Oncology This is a fully remote position, responsible for project delivery, vendor management, budget and will be our main point of contact for the ICON trials.
Please apply if you have 6+ years of clinical research experience with 3+ years running trials in a Project Manager capacity.
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 SPECTRUM
- 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
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