Clinical Operations Country Cluster Head UK & Ireland

United Kingdom
14 Jan 2019
14 Feb 2019


Job Summary:


  • Demonstrate leadership in driving the organization towards established goals
  • Accountability for quality, performance and GCP compliance
  • Overall accountability for legal and regulatory requirement compliance; act as local regulatory expert
  • Accountability for country financial delivery (profitability, utilization and productivity gains as well as prevention of out of scope/contract work)
  • Line management responsibility within a matrix organization between 5-20 direct reports
  • Ensure growth of country operations, develop strategy for expansion
  • Responsible for resource and utilization management, budget spent, delivery on profitability goals 
  • Local key contact for business development/client relations, work closely with strategic clients and ensures client satisfaction
  • Can be involved in local vendor management


Talent Management:


  • Identify strategic staffing needs in country and perform or assist with staff recruitment through screening and interviewing
  • Responsible for detailed performance review and management of assigned direct reports
  • Identify individual training needs and assist with the coordination and conduct of training and development efforts on a country basis
  • Plan, coordinate and conduct on-site CQC (Clinical Quality Control) field visits activities and actively manages the results
  • Effectively communicate management strategies, policies and procedures in conjunction with leadership teams
  • Develop and maintain effective relationships with management team to manage Country staff in a matrix environment across functions
  • Maintain good working relationships with internal and external clients to ensure opportunities for acquiring additional new business


Leadership Responsibilities:


  • Set goals and is accountable for the organizational growth, productivity enhancement, quality delivery and employee engagement
  • Align priorities with strategic direction, execute local operational and strategic plans, ensuring local, regional and global alignment
  • Mobilize, motivate and engage staff, encourage mutual support, drive the culture of self-reporting and of taking ownership, prevent conflicts
  • Develop strategies to control and improve financial margin and maximize utilization across cost centers, projects, and/or initiatives while maintaining quality.
  • Accountable for budget across cost centers, projects, and/or initiatives.
  • Engages with Covance’s leadership to help drive and implement the department’s initiatives
  • Ensures effective cross-functional teamwork including both internal and external ancillary services
  • Presents at external and/or internal meetings
  • Defines and manages resource needs and establish succession plans for key resources.
  • Delivers visible leadership through effective problem solving and generation of custom solutions
  • Finds creative and cost-effective ways to meet quality metrics agreed with key stakeholders


GCP Oversight & Quality Management Accountability:


  • Accountable for the country staff compliance with eTMF and CTMS tasks (timeliness, accuracy & quality)
  • Have GCP oversight of direct reports by ensuring GCP training is executed, understood and implemented
  • Contribute to ‘at risk’ sites identification, rate site risk criteria and determine prioritization of CQC visits in the country.
  • Perform Targeted CQC visits to the sites as an Assessor (if qualified) to evaluate site’s GCP compliance and CRA’s qualifications.
  • Responsible for remediation of GCP issues identified and to support the CAPA resolution at the country level and development of country/regional preventative actions.
  • Is accountable and responsible for execution of the country Quality Plan and delivering on country quality metrics.
  • Provide input to relevant SOPs and standard plans/templates for use by Project Management, Study Start-Up and Clinical Operations staff
  • Ensure GCTO staff are compliant with project plan and adherence to contract obligations in source data verification, monitoring visit cycles, trip report quality and on time deliverables


Productivity/Financial Management:


  • Own and deliver to the agreed productivity goals
  • Perform weekly review of direct report billable hours and associated productive utilization per the quarterly and annual budget plan, escalate outliers and assist the management team with mitigation
  • Responsible to deliver to yearly productivity savings, measured in unit based cost reduction
  • Escalate available workload hours, in context of project allocation, supply and demand, to management team
  • Engage in resource management activities for direct reports or across a project team





  • University/college degree – life sciences preferred or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology)

Essential experience:


  • Extensive relevant clinical research experience in a pharmaceutical company or CRO.
  • Proven experience in managing quality performance of CRAs and in-house staff
  • Thorough knowledge of drug development process.
  • Thorough knowledge of relevant SOPs, ICH, and GCP guidelines.


Preferred experience:


  • Knowledge of resource management systems.
  • Demonstrated ability to inspire effective teamwork and influence staff within a matrix system.
  • Ability to understand and assess technology alternatives and implication for current processes.
  • Knowledge of human resource and employee performance appraisal processes.

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