Clinical Trial Manager
LINE MANAGER / SUPERVISOR JOB TITLE / POSITION – CLINICAL PROGRAMME MANAGER
Purpose of Job
Contribute to the execution of gene therapy studies per development plan, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed in accordance with SOPs, policies and practices.
- Prepare and submit HRA application package for clinical trial approvals in the UK, and support approval application process in the US.
- Negotiate budgets and trial agreements with sites.
- Approve invoices within scope of agreed budget for assigned studies.
- Accountable for site management and communication with sites
- Accountable for site initiation activities including feasibility and the regulatory site activation process
- Liaise with data management team and external vendors to ensure data is reported accurately and in a timely manner for the responsible studies.
- Responsible for outsourced vendor management oversight and invoicing for responsible studies.
- Accountable for TMF review and maintenance of clinical operations inspection readiness for studies.
- Collaborate internally to ensure clinical milestones are achieved and to ensure issues and obstacles are managed accordingly.
- Regularly review site and team communications, Monitoring Visit Reports and quality assurance audit findings to assess quality issues within the project. Implement corrective action plans and ensure appropriate escalation through the team.
- Conduct co-monitoring visits.
- Contribute to compilation and delivery of study associated documentation (protocols, IB, ICF, etc).
- Ensure investigators and research staff training needs are met.
- Establish and maintain good communication and relations with stakeholders in the clinical studies including investigators, CROs, and regulatory consultants.
- Contribute to the development of the clinical quality management system through the development and review of Standard Operating Procedures and supporting documents.
- Contribute to audits and inspections as requested.
- Accountable for set up and maintenance of Trial Master File.
Key Performance Indicators
- Clinical trial management of MeiraGTx Gene therapy studies using industry standard project management tools and training materials and compliance with Good Clinical Practice, standard processes and procedures.
- Implement continuous improvement activities for gene therapy studies.
Key Job Competencies
- 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 Reports: none
- Financial authority: none
- Educated to Degree level (or equivalent) in a Biological Science discipline.
- 5+ years of clinical trial management experience to include trials of an advanced medicinal product.
- 2+ years of clinical trial management experience in a commercial setting.