The Role:You will Support Regulatory processes and systems in the production and archiving of Regulatory Submissions supported by the Submission Operations team. Key Responsibilities:Creation, formatting...
CLINICAL TRIAL MANAGER - PERMANENT - GREATER LONDON - GENE THERAPY
2 x Clinical Trial Manager - full-time, permanent, office-based opportunity in Greater London. I am supporting one of SRG's clients that is growing from strength to strength and would like to invite like-minded individuals to join them on a journey to develop and commercialize innovative gene therapy products that will transform the lives of patients. Given the size of the client and their continuous growth I am happy to speak to experienced candidates who are ready to join a start-up working environment and add value to the future company's expansion.
Clinical Trial Manager will support 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 on time and within budget and in accordance with SOPs, policies and practices. CTM will also ensure regulatory compliance in terms of MHRA, FDA and EU framework.
- Prepare and submit HRA application package for clinical trials approvals in the UK, and support approvals application process in the US.
- Support project team members to be compliant with current ethical and regulatory guidelines and requirements.
- Maintain knowledge of therapeutic area, current GCP and Statutory Instruments.
- Collaborate with the study teams to ensure clinical milestones are achieved and to ensure issues and obstacles are managed accordingly.
- Develop study management plan, project team assignments and provide oversight of databases.
- Report on team performance against contract and project expectations.
- Mitigate clinical risk by problem solving and contingency plan development.
- 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 throughout the team.
- Conduct co-monitoring visits.
- Identify and contribute to compilation and delivery of study associated documentation (protocols, IB, ICF, etc).
- Review trial data and procedures ensuring good quality data.
- Ensure investigators and research staff training needs are met.
- Establish and maintain good communication and relations with stakeholders in the clinical programmes including investigators, CROs, and regulatory consultants.
- Provide input for development of new proposals.
- 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 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.
- No direct Reports
- No financial authority
- Educated to Degree level (or equivalent) in a Biological Science discipline.
- Minimum 5 years of clinical trial management experience to include trials of an advanced medicinal product (gene therapy).
- Minimum 2 years of clinical trial management experience in a commercial setting.
- Eligible to work and live in the UK
- UK experience due to nature of the role and requirements
Training and Development:
On-boarding will be provided and so specific TA is required.
For immediate consideration please send your CV or call/text me on (0) 792 008 7293
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Our team at SRG Clinical also cover roles in Clinical Operations (CPM, CRA etc.), Biometrics (Statistics, SAS programming, Data Management), Medical information, Medical affairs, Pharmacovigilance and Regulatory affairs so do not hesitate to contact SRG Team.
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The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.