- Responsible for the supervision of assigned direct reports
- Responsible for detailed performance review and management of assigned direct reports including: Annual Performance Management and Development (PMD), Individual Development Plan (IDP), Line of Sight Goals and “Shoves & Tugs”
- Responsible for appropriate management and resolution of performance issues
- Measure performance indicators for assigned staff within Clinical Operations.
- Identify individual training needs and assist in the conduct of training and development efforts, regionally
- Conduct on-site Accompanied Field Visit activities (Evaluation and Quality Control Visits) for Clinical Operations staff
- Effectively communicate management strategies, policies and procedures in conjunction with leadership teams
- Develop and maintain effective relationships with management team to manage Clinical Operations staff in a matrix environment.
- Maintain good working relationships with internal and external clients to ensure opportunity for acquiring additional new business.
Indicate the number of:
Direct Reports: Between 10 and 20 Clinical Operations Staff dependent upon business need
GCP Oversight Accountability
- Has GCP oversight of direct reports by ensuring GCP training is executed, understood and implemented.
- Identify and escalate 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
- Provide input to relevant SOPs and standard plans/templates for use by Project Management and Clinical Operations staff.
- Assist with on-boarding of new direct reports ensuring GCP training before monitoring begins
- Hold Clinical Operations staff accountable for GCP issue escalation to the management team, the sponsor and QA, as appropriate.
- Hold Clinical Operations 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 Clinical Operations staff to own effective Investigator relations and Investigator oversight at the local level.
- Communicate status of assigned workload for metric reporting
- Perform weekly review of direct report billable hours and associated utilization per the quarterly and annual budget plan, and escalation of outliers to management team for mitigation
- Escalates available workload hours, in context of project allocation, supply and demand, to management team
- Adheres to global tools for monitoring and utilization forecasting
- Engage in Resource management activities for direct reports
- Assist with staff recruitment through screening and interviewing
- 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 internal and external customers in relevant process improvement initiatives, including Six Sigma
- Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity
- Schedule Accompanied Field Visits to ensure costs are in alignment with regional budget.
- GCP(Good Clinical Practice) の知識と関連する指導経験
- 15年以上の医薬品臨床開発の知識と経験 (モニタリング、プロジェクトマネジメント)
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