Clinical Project Manager (Ophthamology / Gene Therapy)

Job details Salary $500 - $750 a day Job Type Contract Full Job Description Description I’m working with a fast growing ophthalmology / gene therapy focused biotech who are seeking multiple Clinical Project Managers across the UK and US to join a dynamic team responsible for the oversight planning and execution of assigned clinical studies to support product development. This role will be responsible for all assigned studies – clinical operational oversight as well as the execution of monitoring of study deliverables, performing protocol-related site management activities, participating in study planning and set-up activities including vendor management, project management, coordination of study and implementation plans?and supporting third party vendor relationships. Overseeing new clinical studies within their developing pipeline Working with fellow operational team members to ensure consistent operational execution over study program To be an active member of the operational team and help drive the department’s evolution and success To adopt a ‘site-centric’ role creating relationships with assigned key sites, Investigators and site personnel Role Responsibilities: Responsible for the oversight and day-to-day management of clinical operations activities Ensure that the planning, implementation, coordination and reporting of the clinical studies in line with the corporate objectives Act as a key study contact for studies and effectively plan and communicate study milestones, deliverables, timelines and quality standards to other functions and other stakeholder groups Support and mentor team of Associate Clinical Project Managers/Clinical Trial Associates assigned to studies Support and monitor CRO and third-party vendor activities, including IMP management, Investigator contract/budgets, TMF management, study set-up, project management, biostatistics and medical writing Monitor progress of studies, identify study-related trends/issues and work with the Senior Clinical Operations team to implement corrective actions when necessary Attend site visits (including, but not limited to, Site Initiation Visits and study surgeries) where local and national travel policies allow Work with the study team to develop recruitment strategies Through adoption of a site centric model, liaise directly with assigned sites to ensure maintenance of site relationships, troubleshoot study related issues and impart key messaging to the site Prepare and/or review Study Plans, Vendor Specifications and Scopes of Work Contribute to the preparation, design and/or review of essential regulatory study documents, ethics and other required local/national submission requirements Drive the identification and selection of clinical trial investigators as per clinical operations strategy In conjunction with Surgical Technical Expert Liaison, oversee execution of the Surgical Training Plan Adopt a Risk Management approach to oversight and execution of assigned clinical studies Coordinate with CMC for the shipment of IP and ancillary supplies to investigator sites Coordinate and/or lead contract and budget negotiations with sites and third-party vendors Lead study operational and/or scientific feasibility, and site set-up activities as per clinical operations strategy Prepare study training materials and present at Internal Workshops and Investigator Meetings Set up and chair study meetings when required Ensure study certifications, insurance, licenses and registrations are maintained Cross Functional Interactions: