Covance Job - 32763201 | CareerArc
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Company: Covance
Location: Tokyo, Tokyo, Japan
Career Level: Associate
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job Overview:

At Covance, you can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities.

 

 

COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.

You can make a difference by helping to deliver life-saving and life-enhancing medicines to people around the world. Our commitment to this mission has resulted in Covance's impressive history of company stability and growth. We've achieved these results by fostering a work environment that encourages, develops and leverages our team's capabilities. 

This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.

 

People Responsibilities:

  • 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

Indirect Reports: None

 

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.

 

Productivity/Financial Management

  • 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.

 

Education/Qualifications:

familiar with JGCP

business level English

Bachelor degree or above

Experience:

at least 10years experience for clinical operations

lead experience


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