Manager, Quality

About the Role

We are seeking a Manager, Early Phase Risk and Compliance to join our team in a hybrid capacity. As a Manager, Early Phase Risk and Compliance, you will lead and manage Risk and Compliance Leads who support Early Phase Clinical Units, driving strategic initiatives that enhance quality and ensure compliance with regulatory requirements, client expectations, and internal policies. This position plays a key role in risk management oversight, quality support for clinical trials, and regulatory compliance across Early Phase Clinical Units (EPCUs). You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to study operations from planning through closeout.

Responsibilities include leading risk management initiatives, overseeing compliance with Parexel standards and regulatory requirements, managing and developing direct reports, and serving as a strategic partner to senior leadership. With diverse teams and continuous learning opportunities, the Manager, Early Phase Risk and Compliance can explore career paths and expand skills across clinical research and quality management.

Key Responsibilities

• Lead and manage Risk and Compliance Leads, establishing individual contributions to departmental goals and supporting achievement of collective objectives
• Oversee EPRCM-specific risk management initiatives, identifying, categorizing, and scoring risks while developing and implementing effective mitigations across clinical trials and EPCUs
• Ensure compliance with Parexel standard operating procedures, regulatory requirements, and applicable curricula, while verifying accurate time recording and performance management for direct reports
• Lead facility inspection readiness checks and coordinate regular risk reviews to identify, categorize, and score potential risks and quality issues, confirming mitigations are integrated into departmental planning
• Prepare for and support sponsor audits and regulatory inspections, partnering with Quality Assurance to oversee internal audits and serve as an escalation point for critical issues
• Establish and sustain client relationships, serving as Account Risk and Compliance Lead (ARCL) when assigned, including client-level risk management, quality oversight, and quality agreement development
• Attract, recruit, retain, and develop EPRCM staff through engagement, training, performance measurement, and constructive feedback focused on individual development
• Identify opportunities to enhance the Quality Management System and Risk Management through feedback, process improvement initiatives, and participation in Quality Forum and Quality Review Board activities
• Mentor EPRCM Leaders and Risk and Compliance Leads, facilitating induction, designing training, and providing feedback on progress

Candidate Profile

You'll thrive in this role if you bring:

• Excellent communication skills, including verbal and written communication, active listening, and ability to facilitate group discussions
• Strong interpersonal skills with ability to develop relationships, build rapport, persuade and influence teams, and develop talent
• Expert project management capabilities with strong organizational and planning skills, combined with competency in risk management and thoughtful action planning
• Personal awareness and emotional intelligence, with ability to self-motivate, innovate, delegate, and manage time while taking ownership of deliverables
• Robust skills in interpreting, synthesizing, and extracting pertinent data to identify areas of risk, trends, and aggregated issues
• Adaptability to changing environments, ability to think quickly, manage ambiguity, and learn new tasks
• Quality-oriented mindset with strong attention to detail, initiative, and accountability for deliverables
• Expertise in managing the complexity of a matrix environment while valuing teamwork and collaboration
• Ability to travel up to 10% as needed

Required Qualifications

• 8 or more years of experience in clinical research or equivalent
• 1-5 years of experience managing people
• Expertise in ICH-GxPs and regulatory requirements
• English proficiency in written and oral communication
• Strong communication, organization, and problem-solving skills

Education

• Bachelor's Degree in life science or health-related discipline
• Master's Degree in a science, technology, or industry-related discipline