Covance Country Cluster Head, UK & Ireland in Maidenhead, United Kingdom

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

Provide operational leadership for a cluster of countries in driving the organization towards established goals (people, business, client & quality)

  • Act as Country Head for the country where based

  • Lead and manage a team of Country Heads and operational managers within cluster

Have overall accountability for quality, performance and GCP compliance within the cluster

  • Have overall accountability for legal and regulatory requirement compliance

  • Have overall accountability for country cluster financial delivery (profitability, utilization and productivity gains as well as prevention of out of scope/contract work)

  • Ensure consistency and efficiency of processes and policies for Operations staff (Clinical Operations, Flexible Solutions and Country Start-Up)

  • Have overall accountability for the cluster profitability (measured as Country Margin) and in partnership with the Head Clinical Trial Operations, deliver on the Regional growth target

  • Ensure growth of business in the region in cooperation with Business Development and senior management and develop and maintain effective client affiliate relationships in the country cluster

  • Have talent retention and development responsibility, is accountable and responsible for maintaining, building, developing and recruiting highly motivated, high-performance regional teams to deliver to client expectations

  • Accountable for site activation commitments for individual countries being achieved on time and to budget

  • Further enhance reputation of Covance organization, promotes Covance’s brand name

  • May have additional operational assignments for the wider region or strategic initiative assignments

  • Establish operational objectives and/or assignments for Country Heads, Clinical Operations Managers and Start-Up Country Managers

  • May act as back-up for the Head Clinical Trials Operations

Leadership Responsibilities:

  • Provide leadership for the dissemination of Covance’s values, vision and mission at the cluster level and lead, direct, mentor the country heads in line with the organizational strategy

  • Implement short-term and long-term strategies to improve Operational efficiencies across

  • cluster of countries (Operational Excellence)

  • Set goals and is accountable for the organizational growth, productivity enhancement, quality delivery and employee engagement

  • Align regional 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 Search for ways to increase client satisfaction

  • Lead by example

  • Create succession plan for talented Country Heads and Clinical Operations Managers

People Responsibilities:

  • Overall line management responsibility for the recruitment, training, development and performance review of Country Heads within the region

  • Accountable for indirect line management of all employees in the country cluster within a matrix organization and direct line management responsibility for assigned staff; ensures general training and quality control of all staff

  • Responsible for appropriate management and resolution of performance issues

  • Ensure high level of employee engagement of all country cluster staff by addressing employee engagement survey results with implementing suitable and successful mitigation strategies

  • Actively support and drive companywide staff retention strategies for country personnel

  • Responsible to liaise with other functional counterparts, including Project Management, Study Start-Up and Flexible Solutions Leadership as necessary to deliver successful projects/programs and to have productive working best practices established

  • Identify strategic staffing needs in the cluster and perform or assist RTA with staff recruitment through screening and interviewing

  • Develop and measure performance indicators for assigned staff within Operational staff and managers

  • Identify individual training needs and assist with the coordination and conduct of training and development efforts regionally whilst ensuring compliance with Covance policies and procedures

  • Supervise the CQC (Clinical Quality Control visits and MCQV for FS staff) field visits activities within the region and actively manage the results using the CAPA process principles

  • Effectively communicate management strategies, policies and procedures in conjunction with leadership team

  • 5-10 direct reports, 100-400 indirect reports

GCP Oversight & Quality Management Accountability

  • Be accountable and responsible for the execution of the regional Quality Plan and delivery on regional quality metrics.

  • Maintains operations so that the cluster of countries is always in a state of inspection readiness

  • Accountable for the country cluster 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

  • Assist with execution of a global process for identification of ‘at risk’ sites, contribute to further development of the Quality initiative. Oversee execution of Targeted CQC visits by Assessors at the regional level. With assistance of the Regional QC manager be responsible for remediation of identified GCP issues and development of country/regional preventative actions.

  • Responsible for remediation of GCP issues identified and of CAPA resolution at the country level and development of country/regional preventative actions

  • Own and ensure training record compliance with training matrix and ensures up to date training records for cluster

  • Provide input to relevant SOPs and standard plans/templates for use by Project Management and Operations staff

  • Hold all staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate and determine regional implications for corrective action plans

  • Hold all staff accountable for compliance with project plan and adherence to contract obligations in source data verification, monitoring visit cycles, trip report quality and on time deliverables

  • Coach all staff to own effective investigator relations and investigator oversight at the local level

Productivity/Financial Management

  • Be accountable for resource and utilization management, budget spent and delivery on country profitability goals within the cluster

  • Is responsible for resource and utilization management, budget spent, delivery on country profitability goals,takes on full P&L accountability of the country cluster

  • Responsible to deliver to yearly productivity savings, measured in unit based cost reduction

  • Provide assistance with mitigation and corrective action plans for utilization outliers or out of scope activities per the quarterly and annual budget plan

  • Deliver on the utilization and country profitability targets (Country & Operating Margins)

  • Participate in the development of global tools for monitoring and utilization forecasting

  • Coordinate resource management activities across project teams or regionally

  • Accountable for expense management, expense report approval and compliance with Travel Policy of direct and indirect reports

  • 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

  • Support senior management & Facilities group in identifying office location and space, which is scalable for future growth at a competitive cost

  • May serve as a project liaison for clinical operations activities for assigned projects, as required

  • May act as Country Head for additional countries besides the one of residence

  • May manage PartnerCRO(s)

Operational Delivery

  • Study Initiation and enrolment readiness: In overseeing the metrics of Start-Up performance of the cluster, ensure site activation commitments for cluster are met, mitigation plans are developed to drive delivery; and sufficient resources are available.

  • Ensure involved countries of the cluster meet their 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

  • Timely assignment of flexible solutions staff to FS clients

Business Development

  • Represent main point of contact for local clients and new businesses across integrated service offerings of Covance

  • Support bid-defence meetings as an expert in a therapeutic or geographic area

  • Search for new clients and business opportunities across Covance service offerings

  • Develops networks and partnerships with national and international health institutions

  • Shares opportunity information with other Covance internal sales function

Represent the wider region with assignments as SME or Single Point of Contact (SPOC)

  • May act as SPOC for the TA portfolio delivery teams: participate in portfolio and project reviews and clinic days and represent ClinOps for the wider region. Share key information with other cluster heads and leadership (e.g. resourcing, financial, performance or quality)

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.

Job Number 2018-21309

Job Category Clinical Operations

Position Type Full-Time

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