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Interested in an opportunity with a business that is offering a game changing approach within our industry?

Have you got a proven track record of working in a Quality Management position in Clinical Research?

If the answer to those questions is YES, then you need to read on.

We are currently looking to recruit a Territory Quality Manager, working remote/from home, covering the UK and Germany.

This individual will be the lead and subject matter expert on the operational quality management framework across the two countries. They will drive and deliver operational quality and process improvement initiatives, ensures quality training and compliance across the geographic area to increase operational quality, efficiency and long-term business success.

The Territory Quality Manager will also provide consultation on operational quality, risk and regulatory and legislative compliance to sites/functional departments.

#LI-RF1

#LI-Remote

Key roles and responsibilities for Territory Quality Manager are as follows –

  • Provide quality focused and support to the Territory Director (TD) to establish quality and regulatory compliance at site level across the territory to achieve commercial objectives.
  • Actively contribute in the selection process of Partner Sites, following relevant procedures for approval and oversight.
  • Support the reporting and follow up of Quality Issues and CAPAs within the region
  • Identifies Operational Compliance performance metrics and provides required reports to Territory Director, as appropriate.
  • Provides guidance on SOPs, GxP, and all applicable regulatory body and international standards to improve quality and expertise within the site.
  • Safeguards confidentiality of staff, patient and sponsor matters as required by regional GDPR or HIPAA and Good Clinical Practice expectations.
  • Act as a resource to ensure patient safety and data integrity are at the forefront of all activities through review and interpretations of quality reports (e.g. audit reports inspection output, complaints)
  • Provide quarterly quality plans and monthly reports and have regular meetings with TD and site management regarding site performance, reported QIs, consultations
  • Support and review Root Cause Analysis and CAPA investigations on a site level. Highlights any auditor findings and proposes CAPA actions and root cause analysis
  • Reports any non-compliance of service level agreements.
  • Responsible for audit preparation and ensuring the audit readiness of site files.
  • Identifies quality compliance training needs of site staff and provides training, as required (i.e. data systems, ISF) and assists with induction of new site staff.

To be considered for this exciting opportunity you will need the following skills & experience –

  • A background of Quality Management in the Clinical Research Industry
  • In-depth knowledge of the audit process, including audit preparation and oversight for sponsor, internal audits (MHRA Inspection experience will be advantage), as well as root cause analysis and CAPA management
  • Excellent understanding of the requirements that must be submitted to the Ethics Committee  
  • Expert working knowledge of GCP
  • Guidelines and local regulations/expectations pertaining to clinical trials
  • A collaborative approach with the ability to sustain/improve cross functional relationships
  • Comfortable with up to 30% travel, when required/able to do so

Interested? Great, please apply ASAP as we may close the advert prior to the closing date.

AES is an equal opportunities employer.

Competitive Salary + bonus + benefits

Additional Benefits: 25 days annual leave plus bank holidays (increases with service), 5% matched contribution pension scheme, 3x Life Cover, access to our High Street discounts portal, Employee Assistance Programme, Employee Health Cash Plan programme, Cycle to work scheme, enhanced sickness and family friendly policies, excellent training and development opportunities.

Accelerated Enrolment Solutions (AES) is a business unit of PPD that offers both sponsors and contract research organizations best-in-class site and enrolment solutions, with tiered offerings combining the expertise, as needed, of industry leaders PPD, Synexus, Acurian and Optimal Research.

The array of AES services includes strategic enrolment solutions that offer speed, certainty and commercial value to our clients.

Acurian and Synexus have proven track records for enrolling patients and study conduct through proprietary, direct-to-patient recruitment methodologies and a global site network. When combined, these services provide a new standard of clinical trial productivity that delivers more patients from fewer sites in less time.