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Job Details

Clinical Operations Country Cluster Head UK & Ireland

Company: Covance
Location: United Kingdom
Reference: 25960
Closing Date: 14 Feb 19
Type: Full Time
Salary (£): Negotiable
Benefits: Competitive

Job Summary:

As our Clinical Operations Country Cluster Head for UK and Ireland, you will be responsible for providing operational leadership in collaboration with other Country Cluster Heads to identify, discuss, and implement best practices and benchmarks across the Clusters striving for operational excellence

Requirements:

 

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

 

 

Qualifications:

 

  • 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.

Apply for this job: Clinical Operations Country Cluster Head UK & Ireland

Contact Information:

Address:  Covance - Maidenhead
Osprey House Westacott Way Littlewick Green Maidenhead United Kingdom
SL6 3QH,
England
Website:  Visit Our Web Site

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