Project Quality & Risk Lead I (Clinical Trials)

What You will Do:

- With LM or experienced PQRL assistance, 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.

- With LM or experienced PQRL assistance, facilitate and drive the risk management process for assigned projects using the available tools.

- With support of LM or experienced PQRL, 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.

-With support of LM or experienced PQRL, 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.

-With support of LM or experienced PQRL, 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 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.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:

 2-5 years’ experience in late phase clinical research

 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.