Manager of Clinical Operations at Pharmaceutical Research Associates, Inc. in Raleigh, North Carolina

Posted in Health Care 13 days ago.





Job Description:

Pharmaceutical Research Associates, Inc.

Manager of Clinical Operations

US-NCUS-ALUS-SCUS-VAUS-FLUS-GA

Job ID: 2022-87726
Type: US-Southeast
# of Openings: 1
Category: Clinical Trial Management

Bayer

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.



Responsibilities

What you will be doing:

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:

  • 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


Qualifications

What you need to have:

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution required
  • 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.
  • Excellent written and oral communication.
  • Has a good knowledge of Clinical Operations processes and systems.
  • Understands interrelation of Clinical Operations functions within the department and across the full clinical trial process
  • Ability to set expectations and monitor employee performance.
  • Strong mentoring and leadership skills
  • Ability to identify and hire strong candidates through hiring processes
  • Comprehensive knowledge of PRAs SOPs, WIs, and other policies and processes required by functional managers.
  • To qualify, applicants must be legally authorized to work in the US, and should not require, now or in the future, sponsorship for employment visa status


Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

PI160781729
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