Senior Clinical Project Manager

2 days ago

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Biorasi

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Contract Clinical Research • Complex Clinical Trials • Digital Therapeutics • Clinical Trial Rescue • Nephrology

201 - 500

Description

• Oversee the complete project lifecycle from planning and start up to execution and close out in alignment with the project work breakdown structure. • Provide leadership to internal and cross functional teams, across various geographic locations by distributing tasks, tracking performance, resolving issues, and managing change to optimize project performance. • May lead or direct the activities for preparation and delivery of key trainings and meetings over the course of a project, ensure all relevant documentation pre/post meetings are completed, distributed, and filed accordingly. • May lead or direct the vendor qualification and selection as well as the performance and delivery of services by vendors throughout the course of the project. • Oversee the timely creation, maintenance, and quality check of the Trial Master File (TMF) starting from the initiation of the project until the final delivery to the Sponsor or archival of the TMF. • Monitor, control, analyse and report on project’s health from financial, timeline, resources, issues and risks perspective; identify and communicate any changes and initiate change orders when necessary. • Oversee the development, collection and tracking of site documentation, regulatory approvals, and IP release process. • May manage site recruitment strategies and campaigns and the communication across sites as needed throughout a clinical trial. • May support clinical activities by coordinating with clinical team to plan monitoring visits and perform trip reports reviews. • Perform periodic review of documentation generation and study conduct to ensure compliance with plans and SOPs. • Attend any branch and role specific trainings and meetings to develop and enhance relevant knowledge, techniques, and skills. • Support project acquisition activities, including but not limited to, proposal development, presentation development, bid grid formulation, site and vendor feasibility and cost estimation.

Requirements

• Bachelor's Degree or higher in a scientific discipline preferred. • Fluent English (oral and written). • 8 years or more experience with Project Management responsibilities, preferably in the clinical research industry. • 5 years or more experience in supervising and managing large cross-functional teams. • Strong problem solving, management and leadership skills. • Excellent verbal, written communication, and presentation skills. • Good Knowledge of Project Management processes and understanding of ICH GCP and applicable regulatory requirements