Clinical Operations Country Cluster Head UK & Ireland
- 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
- 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
- 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
- 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)
- 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.
- 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.