Senior Project Manager - Oncology
Job details
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 deliverablesManages all HQ Operational Activities, including: Establishes, leads and manages Clinical Trial Team (CTT) Supports clinical (drug/vaccine) supplies planningManages deployment and interactions with external vendors (e.g., IVRS, PRO)Initiates planning for Investigator meeting and protocol training.Plans and assesses protocol ancillary suppliesCompletes trial set-up and maintains SPECTRUMSchedules, prepares for, and leads the Recruitment Planning Meeting for the CTTInitiates recruitment/retention planning & enrollment trackingResponsible for tracking study related details (e.g., specimens, queries)Oversees protocol training activities including IMs and CRAs training meetingsEnsures appropriate postings to investigative site portalsResponsible 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 issuesResponsible for operational details at Operational ReviewsResponsible for creating and maintaining project schedule and collaborating with Program LeadSets up and maintains Trial Master File (eTMF)Ensures alignment of budget with protocol needsResponsible for executing protocol within the budgetResponsible for creating and maintaining ADI logsDevelops Site Monitoring Plan (SMP) with input from the monitoring excellence groupDevelops study related manuals (e.g., administrative binder, lab manuals)Manages Emergency Unblinding (EUB) Call Center activitiesCo-authors newsletters with CSApproves contracts, invoice payments and change orders for vendors, as necessaryResponsible for end of study reconciliation (clinical & ancillary supplies)Oversees all HQ close-out tasksResponsible for ongoing monitoring of trial activities, e.g. dashboards, trackingSupports CS activities as needed to achieve CTT deliverablesInterface with External Data Coordination and Data ManagementResponsible for quality control and inspection readiness at all timesResponsible for risk assessment, mitigation planning and execution
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