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Clinical Project Manager

Clinical Operations · Ambler, Pennsylvania
Department Clinical Operations
Employment Type Full-Time
Minimum Experience Experienced

Gyroscope Therapeutics is building something special – a company to preserve people’s sight and fight the devastating impact of blindness around the world. And if we are successful, our gene therapies and surgical devices will offer people the chance to see what they otherwise would have missed.

To be successful we need the right people. People who have passion for helping patients. People who can work as one toward a common goal, have fun and together bring forward the best ideas. People who celebrate success and embrace failure as an opportunity to learn and grow. If you are one of these people, we would love to meet you.

Gyroscope Therapeutics is looking for a Clinical Project Manager 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 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:

Study set-up and management of global phase I-III studies including study set-up, project management, monitoring, data management, bio-statistics and clinical study report  

  • Site, CRO and vendor management experience
  • Evidence & experience of your input into study design
  • Writing key study documents contributing to the preparation, design and/or review of essential regulatory study documents, ethics and other required local/national submission requirements  
  • Demonstrable experience of regulatory and ethics submissions
  • Management of study contracts and budgets including maintaining study trackers to provide financial and management accountability  
  • Pharmacovigilance & Safety monitoring experience
  • Data Management and monitoring

It would be great to see (but not essential):

  • ATMP/GMO/Biologics handling
  • Working within a small to medium-biotech

Thank You

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  • Location
    Ambler, Pennsylvania
  • Department
    Clinical Operations
  • Employment Type
  • Minimum Experience