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Project Quality & Risk Lead II (Clinical Trials)
Parexel International Corporation
Mexico - Any Region - Home Based
Partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the execution of quality SOPs to support operations, leadership and clients.
What You will Do
- Analyze key risk indicators and investigate risk signals by performing,reporting and coordinating risk-based quality evaluations for assigned projects using dashboards, reports, metrics and ther available tools.
- Facilitate and drive the risk management process for assigned projects using the available tools.
- Facilitate identification, investigation and remediation of quality issues as assigned using available tools and methodologies.
-Provide oversight, transparency and tracking of quality issues for assigned studies.
- Assist with preparations, conduct and response/action plan development for audits/inspections as assigned.
Provide expert quality advice as assigned, responding to consultancy requests and requests for SOP deviations using ICH-GCP, Parexel processes, regulatory requirements, applicable country requirements and input of appropriate subject-matter experts.
- Partner with project teams to achieve and maintain inspection-ready state including story board oversight.
Develop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the roles of Portfolio/Client Quality Lead.
- Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requested.
- Maintain compliance with Parexel standards.
- Mentor new PQRLs as needed.QualificationsMore about you
On your first day we’ll expect you to have:
• Good interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback.
• Analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions.
• Ability to develop professional, collaborative relationships both internally and with the client.
• Skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues.
• Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge.
• Ability to plan, organize, prioritize and manage workload independently, keeping the patient and client at the focus.
• Quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables.
• Ability to manage the complexity of a matrix environment while valuing the importance of teamwork. • Ability to travel 30%-50%
Knowledge and Experience: 5+ years’ experience in late phase clinical research Experience using root cause methodologies (5-whys, fishbone diagram, etc.) Knowledge of ICH-GCP principlesEnglish proficiency (written and oral)
Education:
• Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred.
Job posted: 2021-09-16