Clinical Quality Compliance Lead
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About the role
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As a Clinical Quality Compliance Lead you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
Responsible for planning, monitoring, and reporting on quality and compliance for selected clinical trial delivery processes to determine adherence and understanding of ICH GCP requirements and processes
Contributing member of an independent team focused on clinical trial delivery quality assessment for ongoing operations and processes within supported functional areas
- Performs proactive as well as routine evaluation of clinical trial processes to determine adherence to process and procedural documentation through documentation review and active engagement with study team functional representatives
- Helps develop and maintain KPIs, metrics and dashboards to track process quality and compliance
- Provides near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes.
- Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.
- Represent GCP Compliance in meetings as needed.
- Performs other duties as assigned.
- Minimum of 4+ years clinical research experience in pharmaceutical or biotechnology field
- Solid knowledge of drug development, clinical trial management and/or GCP compliance processes
- Proven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programs.
- Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
- Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements
- BS, MS or equivalent in scientific field
- Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
- Effectively resolve conflict in a constructive manner
- Good understanding of clinical trial processes related to sponsor activities, including but not limited to sponsor oversight, issue management, site management and clinical monitoring.
- Medium complexity projects and/or platforms.
- Moderate supervision required, should be able to function collaboratively with all levels of employees
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.
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.
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, colour, 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.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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