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Clinical Trials Quality (PQ&RL II)Job ID 72310BR Argentina - Any Region - Home Based
-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 other 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.
- 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 principles
- English proficiency (written and oral)
- Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred.
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