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2017-39814

2017-39814

Title 
Senior Manager of Clinical Operations - SH (CN)
Job Locations 
-
China
Posted Date 
3/29/2017

More information about this job

Overview

Our rapid global expansion means that the pace of work here at PRA is often fast and our people are challenged daily to maintain the highest standards of best practice.

 

Nowhere is this more so that our Clinical Operations department and as a Manager of Clinical Operations you will collaborate with Project Teams to ensure that your team of China based IHCRA’s and CRA’s are able to deliver demanding clinical trials on time and on budget.

 

Your role will also focus on managing the resources within the team innovatively and effectively, providing training and development opportunities to the team, performing accompanied visits, handling quality issues and supporting the delivery of the overall Key Performance Indicators. There will also be the opportunity to work on global process improvement initiatives.

 

 

 

Responsibilities

The Manager of Clinical Operations is responsible for recruitment, growth, and development of Clinical Operations employees. They provide leadership in the implementation of PRA’s quality initiatives and business processes, achievement of its management goals and objectives within the framework of the company mission, policy and philosophy.

  • Manage and develop PRA employees to ensure high quality work performance and retention of high quality employees.  Specific accountabilites may vary by area of expertise:
    Develops plans to support growth and career development of assigned Clinical Operations employees as well as manage the delivery of quality performance in line with their job description.
  • Ensures staff development and performance feedback are provided through activities such as mentorship and career development
  • Communicates team and individual goals and expectations to ensure direct reports understand their responsibilities
  • Responsible for managing the performance of staff, including providing input into salaries, bonuses as well as nominations for promotion.
  • Promotes a positive and professional work environment that attracts and retains the best talent and delivers services that exceed customer expectations.
  • May conduct assessment visits with staff as required by SOPs 
  • Responsible for the management of resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual expectations by:
  • Reviewing project tasks and timelines and assigning team members
  • Determines level and type of employee resources to meet corporate/client/project objectives 
  • Schedules and reviews project tasks, provides leadership in the delivery of services to clients
  • Provides guidance/insight on aspects of clinical operations, as well as contingency planning, to accommodate projects while identifying potential impacts to the budget
  • Leading Clinical Operations employees in the delivery of services to clients
  • Ensuring staff fulfill their responsibilities in accordance with PRA’s policies, procedures, SOPs, ICH-GCPs, and other relevant regulatory requirements
  • Liaising with other functional managers to ensure consistency within the company
  • Maintaining utilization of all Clinical Operations employees within department goals

Provides leadership and implement Clinical Operations services and productivity improvements to ensure optimal utilization of billable staff by:

  1. Performing metric collection and data analysis to support PRA’s continuous improvement in policies, procedures, and business process
  2. Identifying and implementing process improvements through review of clinical operations SOPs, processes; recommending improvement plans to senior management.
  3. Leading task forces to implement process improvement initiatives
  4. Building teamwork and improving process and productivity by working within and across functional areas
  5. Be a point of escalation (internal) for resolution of issues and conflicts.
  6. Evaluates compliance of assigned Clinical Operations employees with PRA systems and processes
  7. Provides support with proposal development and participates in client presentations and/or bid defense meetings, as required

Qualifications

We are seeking an experienced Manager, who has managed remote and office based Clinical Operations staff within the China.

 

You will have an undergraduate degree (or international equivalent) in life sciences or health-related field from an accredited institution in addition to experience within a similar functional management role.

 

You will be comfortable operating within a truly global environment and can work effectively with new technologies. Substantial experience using computerised information systems including MS Office is required. Clinical trials development experience is required as is a thorough knowledge of ICH and local regulatory authority regulations regarding drug research and development.

 

This is a unique opportunity to give your ideas a global platform, expand your knowledge base with our cross-continent operations and, ultimately, grow your career within an expanding organisation.

 

Fluency in English is required. The position will be office based in Shanghai China.

 

Together with a competitive salary and fixed Allowance we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.

  • Substantial experience using computerized information systems including experience with PC- Windows, word processing, and electronic spreadsheets required
  • Substantial clinical trials development experience is required
  • Experience supervising or managing professional staff in a clinical research environment required
  • Thorough knowledge of ICH and local regulatory authority regulations regarding drug research and development is required
  • Read, write, and speak fluent English; fluent in host country language required.
  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution required.
  • Advanced degree, or its international equivalent, preferred

 

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