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2017-43953

2017-43953

Title 
Clinical Research Manager, Core Team - Beijing & Shanghai
Job Locations 
-
China
Posted Date 
11/24/2017

More information about this job

Overview

As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.

 

At PRA Health Sciences, providing innovative solutions for our clients is what we do. PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

At PRA, borders do not create boundaries. PRA’s success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.

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.

Responsibilities

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 staff by:

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

 

 

In addition to the above:

  • Mentors and trains other Clinical Operations management level employees
    • Designs and delivers relevant training to the Clinical Operations teams and/or management groups.
    • Viewed as a mentor and a go-to resource across all services within the Clinical Operations group and as a subject matter expert by PRA staff outside of Clinical Operations.
  • Displays expertise in the position by:
    • Leading process development / improvement task force Developing tool(s) to improve Clinical Operations processes Acting as a Subject Matter Expert (SME) for various initiatives.
    • Leadership on programs and/or initiatives that are increasingly complex in their scope of services, technology employed, volume, and/or revenue.
  • Assists more senior Clinical Operations staff in the review, development and implementation of short-term and long- term objectives, major plans and programs for each functional group within Clinical Operations.
  • Creates and maintains effective relationships between other PRA business units or functions.
  • Participates in internal/external audits and regulatory agency inspections, as required

Qualifications

Education and Work Experience:

  • Preferably minimum of 2 years of line management experience with solid monitoring experience during tenure as CRA with global and phase 3 studies exposure.
  • Substantial clinical trials development experience is required.
  • Experience supervising or managing professional staff in a clinical research environment required
  • Substantial experience using computerized information systems including experience with PC- Windows, word processing, and electronic spreadsheets required
  • Thorough knowledge of ICH and local regulatory authority regulations regarding drug research and development is required
  • Read, write, and speak fluent English alongside Mandarin.
  • 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

 

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

 

 

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