Quality Specialist

Quality Specialist
Clinical Trials
Location: Paddington, London
Hybrid
3 years' experience in Clinical Monitoring, including at least 2 years' experience in a role equivalent to a Clinical Project Manager/Clinical Team Lead.

Job Overview
This role is assigned to designated Delivery Unit(s), sponsor(s), business line(s) and/or specific tasks as defined by the line manager (LM). The purpose of this role is to carry out and adopt the global Quality Plan according to the specific needs defined by the scope of the assignment, to assist the assigned business line staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines. Contribute to the development and be responsible for the implementation of specific quality improvement initiatives as agreed with the relevant assigned business lines. Provide advice and support to relevant key stakeholders with regards to quality control, risk assessment, risk management, and corrective/preventive actions.

Essential Functions

• Adopt and implement the global Quality Management Plan within the scope of the assignment with the support of a mentoring Quality Manager/Senior Quality Specialist, this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.
  
• Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery. Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management Plan and Risk Management Program, monitor the implementation and delivery.
  
• Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
  
• Work in close cooperation with teams to manage non-compliance, quality issues, assist in planning corrective/preventive actions, as applicable according to SOPs.
  
• Inform the assigned business line and Quality Assurance of quality issues according to SOPs.
  
• Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
  
• May provide assistance during audits and regulatory inspections to the operational teams to the extent agreed with Quality Management and as required by the applicable SOPs.
  
• Prepare periodic reports to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives.
  
• Upon agreement with the Line Manager: Perform any other reasonable tasks as required by the role.
  
  Qualifications
  
• Bachelors Degree Req
  
• 3 years' experience in Clinical Monitoring, including at least 2 years' experience in a role equivalent to a Clinical Project Manager/Clinical Team Lead. Equivalent combination of education, training, and experience.
  
• Sound working knowledge of medical terminology, Standard Operating Procedures (SOPs), International Conference on Harmonization (ICH), Good Clinical Practice (GCP),, applicable regulatory requirements, quality management processes. Knowledge of National and International Regulations and Drug Development processes.
  
• Knowledge of Pharmaceutical industry operations.
  
• Knowledge of corporate standards and SOPs.
  
• Good organizational, interpersonal and communication skills.
  
• Good judgment and decision-making skills.
  
• Good influencing and negotiation skills.
  
• Strong computer skills including Microsoft Office applications.
  
• Excellent problem solving skills.
  
• Ability to travel within the region/country.
  
• Ability to lead and motivate a clinical team. Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.
  
• Fluent in English