Clinical Programme Manager
LINE MANAGER / SUPERVISOR JOB TITLE / POSITION – DIRECTOR
Purpose of Job
Support the planning and execution of gene therapy programmes per development plan, from initiation through to closeout. Ensure that all programme management and deliverables are completed on time and within budget and in accordance with SOPs, policies and practices. The role will highlight any risks, slippages and obstacles with plans to mitigate any issues.
- Contribute to the clinical and business project planning of MeiraGTx Gene therapy programmes.
- Support the Clinical Research & Development (R&D) projects, providing knowledge of all aspects of clinical development including supporting the day to day management of the clinical operations department.
- Collaborate with stakeholders to ensure development milestones are achieved, and issues and obstacles are managed accordingly.
- Support oversight of vendor management.
- Support the communication of timelines across the team members to ensure efficient production, scheduling and delivery of projects.
- Highlight potential risks, and actual issues with quality, budget or timelines to the senior leadership team.
- Provide oversight of project management plan development and assignments.
- Provide oversight of Quality Management components of studies. Escalate potential risks, issues, findings and corrective actions as appropriate.
- Support contract negotiations in relation to study matters.
- Report to senior leadership on team performance against project expectations.
- 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 documents.
- Oversee preparation of study documents, procedures, manuals and study specific training
- Support the oversight of the data transfer process at the vendor level.
- Review final programme budgets.
- Contribute to the development of key study documents such as clinical protocols, Investigator Brochures and Development Safety Update Reports.
- Support the identification of vendors required to support a study.
Key Performance Indicators
- Work with project team and senior leadership team to successfully complete clinical R&D projects to required timescales and budget.
- Deliver clinical programmes to agreed timelines
- Deliver clinical programmes to agreed budget
Key Job Competencies
- Experience of vendor management of complex projects
- Ensure regulatory compliance in terms of MHRA, FDA and EU framework
- Understand and adhere to the principles of ICH GCP and regulatory requirements in both the EU and US
- Direct report – Clinical Project Manager and Clinical Trial Manager
- Financial authority for approving Purchase Orders (POs) according to clinical budget
- Educated to Degree level (or equivalent) in a Biological Science discipline.
- Proven experience of running projects in the gene therapy or advanced therapies arena.
- Significant experience of working in a translational clinical research environment.
- Proven strong project management experience.
- Ability to work unsupervised and yet have strong interpersonal skills to influence; communicate and manage change.
- Broad experience of business operations including Quality Management Systems, awareness of Expenditure and Processing of Requisitions.