Project Quality & Risk Lead II (Clinical Trials)

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.