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Ref: 882498 – Interim Clinical Trials Manager

09 May 2018

Our client based in Central London is recruiting for an Interim Clinical Trials Manager to work on advanced therapy Clinical Trials for a period of 3 months initially.  The successful individual will ensure that all project management and project deliverables are completed on time and within budget and in accordance with SOPs, policies and practices. The role will highlight any risks, slippages and obstacles with plans to mitigate any issues.

Role purpose:
  • 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
  • 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
  • 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.

Requirements include:
  • 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
  • Educated to Degree level (or equivalent) in a Biological Science discipline
  • Experience of clinical trial management experience to include trials of an advanced medicinal product
  • Experience of clinical trial management experience in a commercial setting.

Location: London
Duration: 3 months initially (based onsite in the London Offices)

To register your interest in this opportunity please forward an up-to-date CV to resourcing@pir-resourcing.com or contact Jo on 01480 499580, quoting reference 882498 and advising current availability and anticipated day rate.

Keywords:
Interim, 3 months initially, Central London, Clinical Trials Manager, research and development, communications, project management, clinical, studies.