Site Quality Lead

Put your talents to work at PCM! Whether you work in our Home Care, Clinical Research, Impairments, or Catastrophic Care division, you will support our mission to deliver care and other services that enhance the quality of life of our clients. Be a part of our dynamic client-focused team and make a difference in your career!

Collaborate cross-functionally within the clinical trials division to ensure quality assurance at clinical sites utilized by the company. Contribute as a member of the Quality team for the purpose of ensuring adherence to quality standards, regulatory requirements, and best practices through the lifecycle of clinical trials.

Qualifications

• Bachelor’s degree from an accredited four-year college or university
• Minimum 3 years in the Pharmaceutical, Medical Device and/or Clinical Trials Industry, including clinical project management, or clinical trial site coordination and/or site management experience
• Strong working knowledge of ICH GCP principles
• Enhanced analytical skills related to gathering and evaluating data
• Strong decision-making skills and ability to work cooperatively within the Quality team to create action plans and corrective and preventive actions (CAPA)
• Strong teamwork skills, both intra-team and cross-functional
• Excellent verbal and written communication skills and strong interpersonal skills
• Ability to manage, supervise and coordinate multiple projects and work independently and proactively
• Advanced skills in Microsoft Office products
• Ability to work with global customers across all time zones
• Ability to travel to research sites and events
• Travel 0-20% of the time

Essential Functions/Areas of Accountability

• Assist the Associate Director Site Quality in the development, implementation, and maintenance of the quality management system to ensure compliance with regulatory requirements, industry standards, and organizational policies.
• Participate in the development and review of standard operating procedures, policies, work instructions, job aids, and other Quality documents to promote consistency and compliance in clinical trials at the site level.
• Conduct routine clinical site audits to determine ongoing GCP and protocol compliance, producing timely and accurate audit reports.
• Support regulatory inspections, client audits, and inquiries by preparing documentation, facilitating site visits, and addressing findings as needed.
• Participate in delivering training sessions to clinical trial staff to enhance their understanding of quality standards, regulatory requirements, and organizational policies.
• Assist in the areas of CAPAs, effectiveness checks, and Quality Management Reviews.
• Perform other related duties as assigned.

The typical base pay range for this role is USD $70,400 - $103,000 per year.

Individual base pay depends on various factors, in addition to primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience, skills and other market-based factors.

Available Benefits Include

• Medical
• Dental
• Vision
• 401(k)
• Company Paid Short Term Disability
• Flexible Spending Account (FSA)
• Health Savings Account (HSA)
• Paid Time Off
• Voluntary Benefits

Please contact Carson Moreira-Rego at (866) 776-0127 x387 or at [email protected] today to learn more about our opportunities where you can make a difference in your own career!

Professional Case Management is an Equal Opportunity Employer.