Senior Clinical Project Manager

  • Gyroscope
  • Job type: Permanent
  • Closing by 29/10/2019
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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

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