Clinical Project Manager (Ophthamology / Gene Therapy)

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:

• Collaboration between the Clinical Project Manager and all functions is anticipated
• Close relationship to be built with other stakeholders at regular functional meetings and ability to clearly and concisely present updates and issues to the cross functional team

Skills and Experience:

• Minimum 3 years’ experience working as a Clinical Project Manager in Phase I-IV studies within the pharmaceutical industry or a CRO
• Extensive experience in direct management of study start up activities
• Independent thinker with ability to anticipate issues and risks and to mitigate accordingly
• Team player who is able to prioritise workload in a fast-paced environment

Desired skills

• ATMP/GMO/Biologics handling Ophthalmology experience
• Working within a small to mid-sized Biotech
• Gene Therapy / Oncology / Biologics therapeutic experience