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Clinical Operations Manager

2 months ago

King of Prussia, Pennsylvania, United States PAREXEL Full time

About the Role:

Parexel's Early Phase Clinical Unit is a dynamic and innovative team that supports the development of new medicines. As a Clinical Operations Manager, you will play a key role in leading the clinical team and contributing to the success of our early phase clinical trials.

Key Responsibilities:

  • Lead the clinical team in the development and execution of clinical trials, ensuring timely and efficient delivery of results.
  • Collaborate with cross-functional teams, including Pharmacy, Screening, Laboratory, Clinical, Recruitment, and Project Management, to ensure seamless trial operations.
  • Develop and maintain quality management systems to ensure compliance with regulatory requirements and industry standards.
  • Supervise and train Clinical Research Associates to ensure they have the necessary skills and knowledge to perform their roles effectively.
  • Manage schedules and workflows to minimize unnecessary overtime and ensure efficient clinical operations.
  • Introduce new technologies and equipment to improve operational efficiency and reduce costs.
  • Participate in fiscal objectives and identify opportunities for cost reduction.
  • Oversee stock management and ordering to ensure optimal inventory levels.
  • Assist with hiring and onboarding new staff, including training and orientation.
  • Collaborate with the Medical Director on clinical operations issues and provide support to the EPCU physician staff.
  • Assist project/study teams with study procedures and provide technical support as needed.
  • Provide general management assistance and support to Project Managers.
  • Ensure compliance with Standard Operating Procedures (SOPs), Good Clinical Practices, and industry standards.
  • Take appropriate actions to ensure staff and participant safety in emergency situations.
  • Ensure optimal nightly operations in the clinic and identify opportunities for process improvement.
  • Display leadership and negotiation skills to act as a conduit between participants and staff, vendors, and other stakeholders.
  • Act as a resource and mentor for other staff, providing training and documentation as needed.
  • Present informed consent documents, treatment schemas, and side effects of study-related IP and concomitant medications to trial participants and research team members.
  • Outline study requirements and criteria according to IRB-approved protocols.
  • Ensure all study procedures, laboratory and medical tests, and other assignments are completed, maintaining an environment conducive to meeting protocol requirements and established timelines.
  • Assign tasks and clinical procedures to appropriately trained research assistants.

Requirements:

  • Bachelor's Degree required or relevant work experience.
  • 2+ years of clinical experience in an acute hospital setting or comparable experience in a clinical research environment.
  • Supervisory experience is required.

What We Offer:

Parexel offers a competitive salary range of $80,000 to $100,000 annually, as well as an annual bonus, benefits (dental, vision, medical) available on day one of work, and opportunities for professional growth and development.