Senior Project Quality & Risk Lead

Home Based, US

As a Sr Project Quality & Risk Lead you will partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise to support operations, leadership and clients with GCP clinical trials.

Responsibilities:

• Analyze key risk indicators and investigate risk signals by performing, reporting and coordinating risk signal evaluations for assigned projects using dashboards, reports, metrics and other available tools.
• Facilitate and support 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 role 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. Mentor PQRLs and EP Quality Specialist as needed.
• Very good interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback.
• Superior analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions.
• Very good skills 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.
• Advanced ability to manage the complexity of a matrix environment while valuing the importance of teamwork.

Skills:

• Excellent interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback
• Superior analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions
• High ability to develop professional, collaborative relationships both internally and with the client
• Strong skills 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
• Ability to travel 10% - 15%

Knowledge and Experience:

• 6+ years’ experience in clinical research
• Expertise in root cause methodologies (5-whys, fishbone diagram, etc.) and CAPA development
• Expertise with 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.  Master’s Degree in a science, technology or industry-related disciple preferred.