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Do you have an audit/quality compliance background and line management experience?

Interested in the dynamic clinical research industry?

We are currently looking to recruit a Site Compliance Manager at our Midlands clinical research site in Edgbaston.  

Working 37 hours per week, Monday to Friday, this role will be responsible for providing oversight, mentoring and guidance to staff, ensuring compliance with all appropriate guidelines for legal, regulatory, and site compliance, as well as company policies/procedures.

They will also provide support to the site regarding Quality Management System (QMS), follow-up on CAPAs, preparation for internal / external audits, operational compliance checks, identification and/or support in reporting of QI, communication of any issues with site performance (e.g. monitor feedback forms, audits, noncompliance from any source).

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Key responsibilities for the Site Compliance Manager are as follows:

  • Lead, coach and line manage the Site Compliance team
  • Prepares individual/site operational compliance plans and performs quarterly operational compliance check activities.
  • Prepares associated reports and follows up on quality issues from all sources and related CAPAs.
  • Performs regular quality control and oversees that quality of data is accurate, on time and adheres to latest approved SOPs, COP’s standards, GCPs, Local Regulatory and protocol.
  • Validates and checks quality of essential documents, participant files and site study data, ensuring accuracy of data entered and source documents and reports discrepancies.
  • Develops, maintains and produces a dashboard for tracking patients, flow of CRFs, and queries, ensuring that this is provided in a timely manner.
  • Conducts, hosts, and produces meeting minutes and actions for departmental and other relevant meetings, ensuring that issues impacting on business are highlighted to senior leaders as needed.
  • Monitors quality and training processes to ensure appropriate timelines are met
  • Liaises with monitors, client representatives, and internal and external clients.
  • Completes the preparation for monitoring visit duties and audits and clarifies concerns related to CRF completions; resolves queries as well as CAPA reporting and basic root cause analyses.
  • Identifies trends in data queries and escalates appropriately.
  • Supports QA regarding notifications, preparations and facilitation of client audit and regulatory inspections, investigations of quality issues and tracking and follow up of local CAPA status.
  • Ensures that quality and patient safety are at the forefront of all activities through review and interpretations of audit reports, quality statistics and operating procedure robustness, and follows up on quality issues.
  • Ensures robust application and compliance with Good Clinical Practice and Data Protection Act or SOPs, QA and applicable regulatory guidelines

To be considered for this exciting opportunity you will require the following skills and experience:

  • Professional knowledge of theory and techniques in the data and compliance field
  • Comprehensive industry knowledge of quality compliance, Good Clinical Practice (GCP)
  • Line management experience
  • Strong understanding of the audit process, including audit preparation and oversight, sponsor, internal audits regulatory authority and FDA will be advantage), as well as CAPA reporting and basic root cause analyses
  • Experience with the preparation of and collation of regulatory documents for ethics submissions
  • Strong multitasking and project management skills
  • Strong interpersonal, leadership, and consultative skills
  • Good working knowledge of Business English
  • Appropriate MS Office Skills
  • Strong medical terminology knowledge
  • Strong time management skills
  • Thorough attention to detail

Interested? Great, please apply ASAP as we may close the advert earlier than the expiry date. 

AES is an Affirmative Action and Equal Opportunity Employer.

Bonus: up to 10% based on site performance. 

Additional Benefits: 25 days annual leave plus bank holidays, 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 Enrollment Solutions (AES) is a business unit of PPD that offers both sponsors and contract research organizations best-in-class clinical trial research site and patient enrollment solutions, with tiered offerings combining the expertise, as needed, of industry leaders PPD, Synexus, Acurian and Optimal Research.

Our success is based on a simple, but crucial, principle. We place the patient at the heart of everything we do. Synexus is a world class Site Network Organisation with global expertise spanning patient recruitment, trial planning, management and patient retention.

We recruit and retain more engaged patients, at fewer sites, and in less time than traditional centres, enhancing the quality and efficiency of our customers’ drug development programmes.