Clinical Project Manager - Ophthalmology - Hertfordshire
|Job Type||Permanent Full Time|
|Area||South East, UK & Ireland|
|Sector||ScientificScientific - Other|
|Salary||Competitive basic salary + bonus + benefits|
- This is an exciting opportunity to join an innovative, pioneering organisation that are developing cutting-edge, genetically defined therapies for the treatment of macular degeneration.
They are looking for an experienced Clinical Project Manager to join their global management and scientific team who have extensive experience in gene therapy and drug development and have served in leadership roles at multiple innovative biotech and pharmaceutical companies.
The role will involve:
- Supporting the execution of clinical studies – interventional and observational
- Contributing to the design, content and preparation of clinical protocols, consent forms, monitoring plans and CRF’s
- Identification of clinical trial investigators
- Responsibility for site start up and management
- Coordinate shipment and analysis of clinical biological samples
- Provide input for screening and enrolment progress.
- Contribution and coordination of monitors workshops and investigator meetings.
The successful candidate will have experience in:
- Study set and management of global phase I-III studies
- Site, CRO and vendor management
- Engaging with key stakeholders
- Input into study design & writing key study documents
- Regulatory and Ethics submissions
- Management of study contracts and budgets
- Pharmacovigilance and Safety monitoring
- Data Management and monitoring