Clinical Project Manager
Meiragtx
🇬🇧 United Kingdom
On-site
Manager or above
2 days ago
- ICH-GCP
- IEC
- Excel
- PowerPoint
- Veeva Vault
- GDPR
2 days ago
- Lead day-to-day operational execution of assigned clinical trials from study start up through study completion.
- Accountable for ensuring that clinical trial is executed on time, with high-quality data and in compliance with the protocol, ICH-GCP, applicable regulations and company procedures.Â
- Lead activities related to clinical trial start up, including site identification, feasibility, selection, contracting, budgeting, coordination of regulatory and IRB/IEC submissions, essential document collection, and site activation.
- Direct and oversee  service provider contracts, and investigator site clinical trial agreement negotiations
- Responsible for study budget compliance and partner with key stakeholders to support financial requirements.
- Direct and oversee site and team communications.
- Develop and maintain project management plans and critical path activities.
- Leads the cross-functional Study Team meetings and responsible for ensuring timely follow up and resolution of action items.
- Liaise with all internal stakeholders and external service providers to ensure data is reported accurately and in a timely manner.
- Â Serve as primary operational point of contact for outsourced clinical service provider management and oversight of vendor performance, deliverables, timelines and quality.
- Accountable for oversight of TMF set-up and maintenance, ensuring inspection readiness.
- Collaborate internally and externally to ensure clinical milestones are achieved and to ensure issues and obstacles are managed accordingly.
- Escalate significant performance, quality, timelines or other concerns to Clinical Operations leadership.
- Manage risk by proactive risk identification, implementation of mitigation strategies and contingency plans.
- Supervise the implementation of corrective and preventative action plans (CAPAs).
- Contribute to development of study documentation (protocols, IB, ICF, etc).
- Review trial data and procedures ensuring good quality data.
- Establish and maintain good communication and relationships with external stakeholders including investigators, Key Opinion Leaders, Contract Research Organisations, and external 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 Job Competencies
- Detailed understanding of clinical trial processes and regulations, in particular within the USA, UK and EU.
- Knowledge of ICH GCP.
- IT literacy, particularly in Word, Excel, Powerpoint.
- Experience in use of eTMF (Veeva Vault experience preferred).
- Understanding of GDPR and general data privacy guidelines.
Additional Responsibilities
Role will include some line management of Clinical Trial Managers and/or Clinical Trial Administrators.
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Candidate Background
- Ideally educated to undergraduate degree level (or equivalent) in a Biological Science discipline or related field.
- 5+ years of clinical trial management experience, ideally including trials of an advanced therapy medicinal product (ATIMP) and managing Phase 1-3 clinical trials in a biotech or pharmaceutical environment.
- Strong experience in managing clinical trials from start up through closeout. Including leading and directing CROs, clinical sites and external vendors.
- Strong understanding of ICH-GCP and applicable clinical research regulations.
- Phase 1, First in Human trial management an advantage.
Clinical Project Manager · Meiragtx