Manager Process & Systems Optimization (3 years' fixed-term contract)

4 days left

United Kingdom
17 May 2021
16 Jun 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Summarized Purpose:
Oversight of quality and the hub locations will be responsible for activities such as KPI management remaining compliant with company and regulatory policies and procedures.Manages a team of staff within the department who support process improvement and operational excellence. Participates in initiatives aimed at supporting and ensuring quality operational delivery via efficient and effective processes, associated systems, training and communications.

Essential Functions and Other Job Information:
• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime (if applicable).
• Supports and manages initiatives to develop, optimize and improve processes, associated systems/applications, training and communications. Leads process improvement initiative teams and represents the department in cross-functional initiatives.
• Acts as a responder to CAPAs.
• Manages updates to procedural documents.
• Develops and/or approves training materials and identifies training needs.
• Makes recommendations to prioritize process improvement needs through CAPA actions, process and systems improvements, and metrics/trend analyses. Defines and designs new operational metrics (KPIs and KQIs).
• Develops and/or approves communication methods and materials.
• Collates information to support prioritization of systems-related business needs and processes and develops recommendations.
• Contributes to and approves communication methods, including the department intranet sites and newsletter.
• Responds to client or internal process audits on global processes, systems, or procedures.
• Interprets data on complex issues, leads cross-functional teams and makes good business decisions with minimal support.

KPIs will include:
• Training Compliance
  • Employee and departmental completion of training.

• Procedural Compliance
  • Rollout of procedures (implemented on time, overdue etc.)

• Quality Event Management
  • On time closure of CAPAs that originated from procedural deviations, audits or inspections.

• Regulatory submissions


Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• 1+ year of leadership responsibility

Knowledge, Skills and Abilities:
• Good leadership and management skills
• Effective in process development and improvement, especially as it applies to clinical trials and clinical development
• Strong attention to detail, investigative and analytical skills
• Interpersonal, negotiation and problem solving skills
• Good computer skills, to include an effective understanding of clinical management technology and systems
• Basic understanding of the practices, processes and requirements of clinical trials, to include regulatory guidelines and directives
• Effective oral and written communication skills including the ability to communicate in English, both orally and in writing
• Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting
• Critical thinking skills to drive innovation and develop new ideas related to process improvements

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