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