Summary:
Responsible for executing on clinical strategies to deliver successful operational outcomes across one or multiple clinical trials
Project Details:
- Assist with the evaluation, selection and management of external vendors to ensure successful clinical trial implementation and execution
- Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with GCP and ICH guidelines
- Work closely with the Program Lead to coordinate, track, and manage all logistics in support of the clinical Program
- Accountable for managing study budgets, including invoice and PO management/reconciliation, month end actuals and accruals in support of the Program Lead and Finance
- Liaise with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
- Assist with authoring of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs)
and other clinical documents as necessary
- Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
- Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
- Assist with development and implementation of policies and standard operating procedures (SOPs) to be used in Clinical Operations
Job Experience:
- BA/BS (preferably in industry or healthcare of science field) with 3-5 years progressive experience in clinical operations
- Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance
- Ability to handle a high volume of highly complex tasks within a given timeline
- Ability to lead a cross-functional team in a matrix environment
- Extensive experience managing clinical programs, CROs, budgets, and timelines req
📌 Clinical Project Manager (Firenze)
🏢 Oxford Global Resources
📍 Firenze
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