Clinical Project Manager
LINE MANAGER / SUPERVISOR JOB TITLE / POSITION – CLINICAL PROGRAMME MANAGER
Purpose of Job
Contribute to the execution of gene therapy projects per development plan, from initiation through to closeout. Ensure that all clinical study management and project deliverables are completed on time and within budget and in accordance with SOPs, policies and practices.
- Support project team members to be compliant with current ethical and regulatory guidelines and requirements.
- Support budget negotiation and trial agreements with sites.
- Oversee program budget and provide input.
- Develop project management plan and be responsible for cross functional project meetings
- Liaise with data management team and external vendors to ensure data is reported accurately and in a timely manner for the responsible program.
- Responsible for outsourced vendor management oversight and invoicing.
- Responsible for the communication of timelines across the team members to ensure efficient production, scheduling and delivery of project.
- Accountable for oversight of TMF review and maintenance and for clinical operations inspection readiness.
- Collaborate internally and externally to ensure clinical milestones are achieved and to ensure issues and obstacles are managed accordingly.
- Mitigate clinical risk by problem solving and contingency plan development.
- Oversee site and team communications and compliance with regulations and SOPs.
- Oversee and support quality assurance.
- Supervise the implementation of corrective action plans.
- Oversee activities outsourced to CRO.
- Identify and contribute to compilation and delivery of study associated documentation (protocols, IB, ICF, etc).
- Review trial data and procedures ensuring good quality data.
- Establish and maintain good communication and relations with stakeholders in the clinical programmes 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.
- Provide assistance and participate in audits and inspections.
Key Performance Indicators
- Clinical trial management of MeiraGTx Gene therapy programmes 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 programmes.
- Co-ordinate outsourced vendor agreements and costings
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: Clinical Trial Administrators
- No financial authority
- 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.