Clinical Research Compliance Manager

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Job Title: Clinical Research Compliance Manager

Location: On-Site (London Bridge)

Term: Full Time, Permanent

Salary: Competitive + Benefits (Private Medical, Private Dental, Life Assurance, Private Pension & many more)

Richmond Pharmacology are an early phase Clinical Research Organisation (CRO), where we are conducting pioneering early phase healthy participants and patient participant trials. Our experienced and world-renowned team, our central London location and our global reach contribute to making Richmond Pharmacology an exciting and dynamic place to work.

Purpose of the job:

The CRCM role primarily oversees clinical procedures and ensures accurate, complete data collection adhering to ICH GCP Guidelines, study protocols (CSPs), SOMs, SOPs, and other relevant regulations. CRCM role focuses on promoting, implementing and embedding the culture of 'Do It Right the First Time' for the purpose of ensuring clinical research trials and data quality integrity is upheld at the highest standard in accordance with ICH GCP and other regulatory requirements standards. The role fits in the newly setup functional department - Clinical Research Compliance Department. The new CRCM role encompasses the transformational aspects of being proactive in adherence of clinical compliance standards in all relevant aspects to clinical study.

The CRCMs roles will include the management of all aspects of external monitoring visits, understand the nature of their queries and where applicable verify the validity of such queries in accordance with the ICH GCP standard requirements.

Main duties and responsibilities:

External Monitors and Clinical Research Auditors Management and Reporting:

• Undertake induction and refresher training delivery to EMs/CRAs to ensure Richmond processes and systems are well understood
• Liaise and coordinate with internal stakeholders with all aspects to EMs/CRAs site visits, ensuring the necessary documentation and information availability; and any query related activities are addressed according to ICH GCP best practices in a timely manner.

Training and Education:

• Provide ongoing education and support to ensure clinical research team members are up to date to the latest compliance matters and standards

Quality Assurance and Quality Control:

• Implement and maintain a comprehensive quality control program for clinical research activities.
• Perform internal data quality control to ensure:
  • the quality of clinical procedures performed, and any study data collected to ensure it is complete, correct and conforms to all requirements, ICH GCP Guidelines and other applicable regulations as well as meeting the study criteria
  • accuracy of data collection for all study and in relation to randomised, rejected subject related processes including the quality of data control for reject volunteers as per Richmond guidelines agreed by PIs and Sponsor where applicable.

The above can be achieved by adopting a Risk Base Quality Management (RBQM) approach through the establishment of robust statistical process control using six sigma methodologies

• Support in conduct root cause analyses and oversees the implementation of corrective and preventive actions (CAPA) when issues or deviations are identified
• Ensure proper documentation, data management, and record-keeping practices.

Collaboration and Communication:

• Serve as a liaison between the research team and external monitors, facilitating communication and addressing inquiries or concerns.
• Maintain open lines of communication with research staff and promote a culture of compliance and ethical research conduct.

Risk Management and Mitigation:

• Identify and assess potential risks associated with clinical research activities primarily in compliance perspective
• Implement risk management strategies and mitigation plans to address identified risks.

Continuous Improvement and Monitoring:

• Continuously monitor and evaluate the effectiveness of the compliance program, identifying areas for improvement.
• Implement process improvements and best practices to enhance the overall quality

Documentation and Reporting:

• Maintain documentation of compliance activities, audits, and corrective actions.
• Prepare and present compliance reports to the study team, and other stakeholders
• Maintain the tracking of protocol deviations list and undertake trend analysis

Skills and Experience

• BSc or above in Life Sciences, Nursing or Pharmacy (not necessarily registered in the UK)
• Previous data monitoring experience in CRO or pharma for clinical trials is desired
• Good knowledge of ICH GCP guidelines
• Good knowledge of MHRA early phase accreditations
• Ability to communicate professionally with external and internal professionals

Application:

If you are interested in the role, please register your details, including a copy of your CV. Please note, while we try to respond to every candidate, the high volume of applications anticipated may make this impossible and we ask for your patience and understanding.