Covance

  • Country Cluster Head

    Job Location(s) UK-Maidenhead
    Job Number
    2018-25960
    Job Category
    Other
    Position Type
    Full-Time
  • Job Overview

    As the 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

     

    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 including: Annual Performance Management and Development (PMD), Individual Development Plan (IDP),
    • Responsible for appropriate management and resolution of performance issues
    • 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
    • Develop deep leadership bench
    • Ensures effective cross-functional teamwork including both internal and external ancillary services
    • Ensures that all staff allocated to assigned projects or initiatives adhere to professional standards and SOPs.
    • Monitor team performance and facilitate adjustments when necessary to ensure goal attainment
    • Effectively and proactively resolves conflicts as needed
    • Presents at external and/or internal meetings
    • Defines and manages resource needs and establish succession plans for key resources.
    • Supports business unit utilization targets
    • Responsible for appropriate issue escalation
    • 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
    • Assist with coordination and implementation of on-boarding new direct reports ensuring GCP training before monitoring begins
    • Ensure GCTO staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate and determine regional implications for corrective action plans
    • 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
    • Coach GCTO staff to own effective investigator relations and investigator oversight at the local level

     

    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
    • Liaise with internal and external customers in relevant process improvement initiatives
    • Encourage use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity
    • Liaise with internal/external customers in relevant process improvement initiatives
    • Direct the development, implementation and adherence to relevant SOPs and project plans
    • May serve as a project liaison for clinical operations activities for assigned projects, as required

     

     

    Operational Delivery:

    • Study Initiation: in overseeing the metrics of Start-Up performance of the country, ensure site activation commitments for cluster are met, mitigation plans are developed to drive delivery; and sufficient resources are available
    • Commit to site patient recruitment targets, regularly oversee in-country project status and remove obstacles effectively
    • Support project teams with delivering studies on budget and on time

     

    Business Development:

    • Represent main point of contact for local clients and new businesses across integrated service offerings of Covance (where appropriate)
    • Support bid-defence meetings as an expert in a therapeutic or geographic area
    • Search for new clients and business opportunities across Covance service offerings
    • Shares opportunity information with other Covance internal sales function

     

     

     

    Education / Qualifications

    Required:

    • 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)

     

    Preferred:

    • Masters or other advanced degree

    Experience

    Required:

     

    Relevant clinical research experience in a pharmaceutical company or CRO.

    • Individual is proficient with on site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits).
    • Proven experience in managing quality performance of CRAs and in-house staff
    • Extensive relevant clinical research experience in a pharmaceutical company/CRO
    • Thorough knowledge of drug development process.
    • Thorough knowledge of relevant SOPs, ICH, and GCP guidelines.

    Relevant supervisory experience.

    • Demonstrated ability to lead by example with line management experience in a previous role and to encourage team members to seek solutions.
    • Proven interpersonal skills.
    • Demonstrated ability to successfully participate as a member of a project team.
    • Demonstrated ability to successfully manage multiple competing priorities.
    • Excellent planning and organizational skills.
    • Excellent oral, written and presentation skills.

    Preferred:

    • 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.
    • Detailed knowledge of Covance and the overall structure of the organization.
    • Thorough knowledge of Covance SOPs.

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