Director - Clinical Operations - Covance - Tokyo

Job description
The Clinical Operations Associate Director will oversee the clinical trial operations and strategy for Covance lead clinical studies and help coach and develop our talented team of clinical monitors (CRAs) and managers in Japan. As part of the local leadership team the incumbent will also assist the organization to improve productivity in future.


GCP and Quality Oversight:
• Ensures GCP oversight of direct reports by ensuring GCP training is executed, understood and implemented
• Identify, escalate and manage resolution of GCP issues identified through regular interactions with direct reports and conduct of Accompanied Field Visits
• Ensures training record compliance with training matrix and ensures training records are up to date
• Initiate recommendations and communication of global Project Management and Clinical Operations Training Matrix requirements
• May be responsible for reconciliation of Global training matrices with current SOPs and training requirements
• Review and approve relevant SOPs and standard plans/templates for use by Project Management and Clinical Operations staff
• Act as global and/or regional business unit training representative for iLearn and the training group
• Coordinate and implement on-boarding of new direct report ensuring GCP training before monitoring begins
• Hold Clinical Operations staff accountable to GCP issue escalation to the management team, the sponsor and QA, as appropriate, and determine regional/global implications for corrective action plans
• Hold Clinical Operations staff accountable for quality and compliance with project plan and adherence to contract obligations in Source Data Verification, Monitoring Visit cycles, Trip Report quality and on time deliverables
• Coach Clinical Operations staff to own effective Investigator relations and Investigator oversight at the local leave

Productivity and Financial Management:
• Create regional and/or global metric reports of assigned Clinical Operations work
• Provide assistance with mitigation and corrective action plans for utilization outliers per the quarterly and annual budget plan
• Escalates available workload hours, in context of project allocation, supply and demand, to management team and provides assistance to mitigation plans with management team
• Participate in the development of global tools for monitoring and utilization forecasting
• Coordinate resource management activities across project teams or regionally
• Identify strategic staffing needs and assist in staff recruitment
• Financial authority in accordance with current signature approval matrix
• Accountable for expense management, expense report approval and compliance with Travel Policy of direct reports
• Liaise with and make recommendations to internal and external customers in relevant process improvement initiatives, including Six Sigma
• Evaluates standardized processes and tools in alignment with associated policies to ensure efficiency and productivity
• Management of Accompanied Field Visits costs in alignment with regional budget

Desired Skills and Experience
• Minimum of nine (9) years relevant clinical research experience in a pharmaceutical company/CRO
• Individual is proficient with Japanese regualtory policies, on site monitoring activities (including pre-study, initiation, routine monitoring and closeout visits)
• Thorough knowledge of drug development process
• Thorough knowledge of relevant SOPs, ICH, and GCP guidelines
• Minimum of 5 years as a Line Manager or Project Manager required
• University/college degree (life science preferred) or certification in a related allied health profession from
an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
• Detailed knowledge of financial control procedures (e.g. costing systems, TAQ / EVA).
• Thorough knowledge of time and cost estimate development.
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the
conduct of clinical development programs.
• Fluent in Japanese and English, both written and verbal.

• Demonstrated ability to lead by example 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

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