London, London
Clinical Programme Manager
Permanent
£75,000 – £88,000
Are you an experienced Clinical Programme Manager looking for the opportunity to join a friendly, exciting, and hardworking company?
Our client, a clinical-stage gene therapy company who focuses on the development of treatments for serious diseases such as diseases of the eye, salivary gland, and central nervous system diseases is looking for a motivated and experienced Clinical Programme Manager to join their growing team in London.
As Clinical Programme Manager, you will support the planning and execution of gene therapy programmes and ensure that all programme management and deliverables are completed to schedule and within the financial plan.
Main role:
- Contribute to the clinical and business project planning of gene therapy programmes
- Support the Clinical Research & Development projects, providing knowledge of all aspects of clinical development including
- Collaborate with stakeholders to ensure development milestones are achieved
- Support oversight of vendor management
- Responsible for study or program level reporting of progress, risks, and issues
- Provide oversight of Quality Management components of studies
- Lead the study-related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance
- Facilitate continual improvements to internal processes to improve efficiency
- Participate in internal and external audits as planned and report non-conformances and recommendations for improvement
- Contribute to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting document
- Oversee preparation of study documents, procedures, manuals and study-specific training
- Support the oversight of the data transfer process at the vendor level
- Contribute to the development of key study documents such as clinical protocols Investigator Brochures and Development Safety Update Reports
- Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
- Responsible for ensuring that any GMP documentation is closed timely and in a RFT state
Background/ Education:
- Hold a Masters degree level (or equivalent) in a Biological Science discipline
- Program Management qualifications
- At least 10 years of drug development experience demonstrated in a variety of roles
- At least 5 years of experience leading studies/projects in Clinical Development/Medical Affairs
- Proven experience in running projects in the gene therapy or advanced therapies arena
- Significant experience in working in a translational clinical research environment
- Extensive and proven experience in driving operational delivery – timelines, cost, and quality
- Excellent knowledge of ICH-GCP principles
- Experience in selection of external providers, providing clear requirements, and development/review of contracts
- Proven oversight of external providers
- Broad experience in business operations including Quality Management Systems, awareness of Expenditure, and Processing of Requisitions
- Experience in a variety of academic/CRO/Sponsor organisations and countries
Salary: £75,000 - £88,000
Date Posted: 01/07/2022
