PRAHS

  • Manager of Clinical Operations

    Job Locations (All) | US-Remote
    Posted Date 1 month ago(11/8/2018 3:06 PM)
    ID
    2018-46991
  • Overview

    The Manager of Clinical Operations is responsible for recruitment, growth, and development of Clinical Operations employees, which may include CRAs (Clinical Research Associates) or CTMs (Clinical Team Managers). 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 accountabilities 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 them
    • 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:

    • 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

     

    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
    • 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

    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.

     

     

    Substantial experience using computerized information systems including experience with PC- Windows, word processing, and electronic spreadsheets, required.

     

    Substantial clinical trials development experience is, required

     

    Appropriate direct line management experience of Clinical operations staff; 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, required.

     

    Read, write, and speak fluent English

     

    Travel of up to 50% may be required for this position, if managing CRAs. Exact amounts of travel will vary, pending client needs.

     

    To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

     

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

     







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