Sr. clinical project manager

01 ago - Italia
Allucent

At AllucentTM, we are dedicated to helping small‐medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life‐changing therapies to patients in need across the globe. Responsibilities Leads the project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract Creates and executes project management plans required for project delivery and in accordance with established processes Ensures quality and adherence to the relevant policies, SOPs, and working instructions, GCP and regulatory guidelines. Establishes clear communication lines and escalation pathways, communicates with project stakeholders Provides input on study related documents such as the study protocol, CRF, Medical Review/Monitoring plan, and Clinical Study Report Establishes requirements for and ensures project specific training plan for team activities Leads internal and external meetings, with internal and sponsor teams, including Kick Off Meetings (KOM)



and Investigator Meetings based on project scope Provides support for vendor identification, qualification and selection and manages vendors Manages vendors and vendor relationships as required for project delivery Ensures effective and efficient resource utilization across projects and programs Produces, maintains and circulates project progress and status reports Manages the study budget, including monthly invoicing. Establishes project risk management plan with input from client and functional stakeholders and oversees adherence and updates throughout the project lifecycle Proactively recognizes and addresses any changes in scope Negotiates and influences internal and external team members in a professional manner and with successful outcomes Effectively solves problems with projects teams by applying strategic thinking and conflict resolution skills Ensures the Trial Master File is kept up to date and inspection ready Serves as the primary point of

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