We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA.
Who are we?
We Are PRA. We are 17,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most
What do you need to have?Qualifications:
- 7+ years of clinical trial experience with GCP audit experience preferred
- 2+ years’ experience in a client facing role (e.g. CTM)
- 2+ years’ experience direct management of staff.
- Compliance or auditing experience required.
- Must have thorough understanding of GCP and EC and/or US regulations
- Understanding of all aspects of clinical research, including protocol development, CRF design, clinical trial management (including laboratory methodologies ad clinical examinations), data management, statistical analysis, clinical study reports, and regulatory submissions preferred.
- Read, write and speak fluent English; Fluency in other languages is a plus
- An undergraduate degree or its international equivalent from an accredited institution required. Preferably in the health-sciences or computer sciences.
- Experience in CRO / Healthcare / Pharmaceutical quality assurance activities required
- To qualify, applicants must be legally authorized to work in the United States or Canada, and should not require, now or in the future, sponsorship for employment visa status.
- Travel up to 20%
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
What will you be doing? This role develops and implements client specific quality oversight program(s). This will include, but may not be limited to: Creating and delivering a comprehensive, global quality oversight plan in compliance with company SOPs (Standard Operating Procedures), GCP and clinical trials regulations. Provides expertise and guidance on global GCP topics, identifies compliance and quality trends and areas of potential compliance risk, proposes resolutions, oversees implementation of resolutions, and ensures effectiveness of solutions. Collaborates with internal functional areas to help maintain PRA’s high quality standards of clinical trial development.
- Creating and delivering a comprehensive, global quality oversight plan in compliance with company SOPs (Standard Operating Procedures), GCP and clinical trials regulations.
- Provides expertise and guidance on global GCP topics, identifies compliance and quality trends and areas of potential compliance risk, proposes resolutions, oversees implementation of resolutions, and ensures effectiveness of solutions.
- Collaborates with internal functional areas to help maintain PRA’s high quality standards of clinical trial development.
- Develop, implement and maintain quality oversight plans, tools and templates
- Participates in the selection, hiring and training of new Quality Oversight staff.
- May functionally manage 1- 5 colleagues within a matrix reporting structure
- Leads the implementation of client specific quality oversight plans for assigned clients, projects and/or portfolios.
- Ensures the quality oversight plan is completed according to internal requirements and agreed upon client expectations
- Liaises with project team leads (e.g. PM, CTM, etc.) on identified quality issues, quality/compliance trends, and works within the team to address and mitigate identified risks.
- Advises project team on global GCP regulations and guidance documents governing clinical trial development and serves as expert consultant to project teams and client representatives
- Oversees the development and finalization of all audit finding responses. Includes an assessment of completeness, compliance with GCP and PRA standards, and adequacy of response.
- Facilitates personally and/or ensures facilitation of all project, client and/or portfolio related quality issues (e.g.CAPAs) and ensures effectiveness checks are instituted in a timely manner
- Develops and delivers training on lessons learned through Audits and Inspections
- Leads the evaluation and management of site specific escalations related to persistent or serious misconduct.
- Participates, as requested, on quality related projects initiated by internal stakeholders
- Provides reports on quality trends, observations and suggestions to Management
- Liaises with the QA department in relation to inspection support requests and client audits, as appropriate
- Performs risk assessments and root cause analyses as needed
- Contributes to the development and implementation of the Quality Oversight operating plan
- Assists in the definition of the strategic direction for Quality Oversight
- Communicates with senior management and clients on long range issues, assists in ensuring management objectives are achieved
- Utilizes tools and methodologies to improve individual and team effectiveness
- Performs cross-client reviews to identify trends in quality issues that may warrant further internal escalation
- Develops and mentors Quality Oversight staff.