Your mission
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.
Job Description
Major Activities
- Primary accountability for operational study level time, cost and quality deliverables
- Independently oversees all operational clinical research activities for a study or series of small studies.
- Oversees execution of studies according to ICH/GCP guidelines.
- 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.
- Recommends sites to include or exclude from study.
- 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.
- Monitors and assesses vendor performance against contractual operational deliverables.
- Accountable for TMF review and maintenance of clinical operations inspection readiness.
- 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.
- Assesses risks and proposes creative solutions or options.
- Conduct co-monitoring visits.
- Contribute to compilation and delivery of study associated documentation (protocols, IB, ICF, etc).
- Oversees the development of study manuals and monitoring manuals.
- Ensure investigators and research staff training needs are met.
- Establish and maintain good communication and relations with stakeholders in 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 maintenance of Trial Master File.
- Participate in process improvement activities.
- Makes recommendations for improving resources (tools, systems, vendors etc) needed by the team.
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.
Job Responsibilities
- Direct Reports: none.
- Financial authority: none.
Job background
- Educated to Degree level (or equivalent) in a Biological Science discipline.
- 2+ years of clinical trial management experience in a commercial setting and/or.
- 4+ years being a Clinical Research Associate to a Senior level.
Why us?