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.
About us
MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.
Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.
Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.
