The Phase 1 Quality Risk Management Lead is responsible for leading cross-functional activities that sustain, control, and improve Pfizer's end-to-end clinical trial Quality Risk Management (QRM) process across Pfizer's Phase 1 programs. This includes developing and maintaining process control documentation, utilizing analytical tools, analyzing process control/effectiveness data, identifying and responding to insights from the data, and assessing the effectiveness of systems associated with QRM process execution and oversight. The role is also responsible for analyzing systemic performance and identifying and remediating areas requiring improvement.
In addition, serving as an expert in risk management, the QRM Lead will ensure that the Phase 1 Quality Risk Management Plans are high quality documents that capture and mitigate potential risks that are important in relation to the safety, rights, and wellbeing of trial participants, to the reliability of trial results, and to the compliance with the investigational plan have been identified and successfully controlled. In doing so, the QRM Lead will lead regular interactions with clinical study team members, CDQ LT members, , BT, IM and others to improve the effectiveness of the Quality Risk Management program in support of GPD/WRD performance.
* Lead cross-functional teams that are associated with management of the QRM process and ensure appropriate management, control, analysis, remediation, and documentation
* Lead execution of QRM process control plan - Identify and analyze process control issues; drive escalation, remediation and follow up to completion as needed - Lead QC of process metrics data and coordinate with stakeholders to ensure compliance
* Lead execution of Quality Measures Oversight and Remediation control plan efforts
* BS in a scientific or technical field of study and 10 years of relevant experience, with at least 5 years in clinical development, process quality or risk management.
* Detailed knowledge of clinical trial operational processes and supporting systems and tools
* Detailed knowledge of data and reporting systems
* Effective verbal and written communication skills in relating to leaders, colleagues and associates both inside and outside the organization
* Experience working across multiple levels in an organization
* Experience using data to drive solutions to business challenges
* Experience working with business technology through development and delivery of electronic solutions
* Track record of delivery
* Strong organizational skills
* Strong facilitation and presentation skills
* Able to work effectively across divisional, functional, site and CRO boundaries
* Able to work in ambiguous situations to identify and resolve complex problems
* Excellent collaborator able to partner across stakeholders
* Contributes to a learning environment by sharing knowledge and best practices within and across the organization
EEO & Employment Eligibility
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A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
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