Location: Ambler, PA
Gyroscope Therapeutics is developing gene therapy beyond rare disease and using it to treat a leading cause of blindness, dry age-related macular degeneration (dry-AMD). Currently, 35 million people are affected by dry-AMD around the world and there are no approved treatments.
Our investigational therapy, GT005, is designed to restore balance to a part of our immune system called the complement system. The goal is to slow, or possibly stop the progression of dry-AMD. Patients in our Phase I/II clinical trial receive a single dose therapy through a one-time procedure into the back of their retina.
We are looking for Senior Clinical Project Managers who will work as the lead Study/Program Operational Clinical Project Manager, support the design, planning and execution of assigned clinical studies to support product development, regulatory submissions and post-market evaluation.
The Senior Clinical Project Manager will be responsible for clinical operational oversight as well as the execution of all assigned studies, 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.
What we want to see in your professional experience:
Responsible for the oversight and day-to-day management of clinical operations activities e.g. budgets, milestones, deliverables and timelines, for one or more clinical studies
Responsible for the oversight and management of fully outsourced clinical studies from protocol development through to clinical study report
Ensure that the planning, implementation, coordination and reporting of the clinical studies in line with the corporate objectives
Act as the key study contact for studies and effectively plan and communicate study milestones, deliverables, timelines and quality standards to project team and other stakeholder groups
Support and monitor CRO and third-party vendor activities, including study set-up, project management, monitoring, data management, biostatistics and clinical study report
Monitor progress of studies, identify study-related trends/issues and work with the Director of Clinical Operations and CRO to implement corrective actions when necessary
Travel to include attendance at Vendor Meetings, Investigator Meetings, Society Meetings, recruitment motivational visits and to conduct co-evaluation visits with CRO monitors
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
Review and maintain QMS for clinical programs
In conjunction with Surgical Liaison/Director of Clinical Operations develop Surgical Manual and Training Plan
In conjunction with Project Director, develop and maintain Study Risk Management Plan
Coordinate with CMC for the shipment of IP and ancillary supplies to investigator sites
Work with Research Dept and specialist laboratory vendors to ensure clinical biological sample collection, shipment, storage and analysis
Coordinate and 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 Monitors Workshops and Investigator Meetings
Maintain study trackers to provide financial and management accountability
Set up and chair study meetings, including DSMB, Steering Committee and/or Advisory Board
Act as Sponsor representative and key point of contact for Investigators, KOLs and other external parties
Ensure study certifications, insurance, licenses and registrations are maintained