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Jobs at Parexel

Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting With Heart®? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people With Heart®.

Clinical Trials Quality (PQ&RL II)

Job ID 72310BR Argentina - Any Region - Home Based
Purpose:
-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.

Qualifications

Skills:
- 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)

Education:
- Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred.

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