Your mission
Contribute to the execution of gene therapy and associated projects per development plan, from planning and initiation through to closeout. Ensure that all clinical study management and project deliverables are completed on time, within budget, to high quality and in accordance with SOPs, policies and practices.
Job Description
Major Activities- 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.
- 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.
- 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 ResponsibilitiesRole will include some line management of Clinical Trial Managers and/or Clinical Trial Administrators.
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.
