Covance Clinical Operations Manager / クリニカル オペレーション マネージャー in Tokyo, Japan
1. 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.
Direct Reports: Between 10 and 20 Clinical Operations Staff dependent upon business need
Indirect Reports: None
2.GCP and Quality Oversight:
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 or review of reports from Clinical Quality Control (CQC) 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 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
3. Productivity and Financial Management:
Communicate status of assigned workload of direct reports for metric reporting – via the Resource Forecast Tool
Perform review of direct report billable hours (via Time & Labor) and monthly review of associated utilization, 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
Ensure Clinical Quality Control visits are conducted for newly hired or promoted CRAs in compliance with the program
Top 3 Reasons you should join us:
Energizing purpose. Our work improves lives. Covance has helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. You will personally contribute every day to advancing healthcare.
Exceptional people. We are building a team of Talent Acquisition Business Relationship Managers, Talent Sourcing Recruiters, and Candidate Experience Coordinators to transform Talent Acquisition at Covance. You will learn with the most talented human resources minds, in an agile, supportive, and caring environment.
Extraordinary potential. You will work on the most stimulating and challenging talent challenges, in a flexible work environment, with the training and career development that will help you thrive personally and professionally.
There is no better time to join Covance. Together, let’s shape new possibilities for your career and improve the lives of patients around the world.
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)
In lieu of this required educational background the following relevant work history may be considered:
Minimum of three (3) years supervisory experience in a health care or clinical research setting and
Minimum of seven (7) years relevant clinical research experience in a pharmaceutical company/CRO
- Masters or other advanced degree
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)
Minimum of five (5) years 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
Minimum of 5 years as a Line Manager or Project Manager required
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
Excellent oral, written and presentation skills
In lieu of required supervisor experience the following relevant work history may be considered:
Additional 3-5 years relevant clinical research experience in a pharmaceutical company/CRO.
Job Number 2018-18498
Job Category Clinical Operations
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.