Manager, Early Phase Risk & Compliance

Parexel; United States; Hybrid; USD 140,000 - 180,000; Full time

Job summary

Parexel is seeking a Manager, Early Phase Risk and Compliance to join our team in a hybrid capacity, working on risk management and regulatory projects across Early Phase Clinical Units. You will lead Risk and Compliance Leads and partner with senior leadership to drive quality and compliance across trials.

This role demands excellent communication, strong project management, and the ability to mentor staff while delivering strategic risk mitigation and audit readiness in a fast-paced

Qualifications

• Excellent communication skills, including verbal and written communication.
• Strong interpersonal skills to build relationships and influence teams.
• Expert project management capabilities with planning skills.
• Emotional intelligence and self-motivation.
• Ability to interpret data to identify risks and trends.

Responsibilities

• Lead and manage Risk and Compliance Leads to meet departmental goals.
• Oversee risk management initiatives across EPCUs.
• Ensure regulatory compliance with SOPs and regulatory requirements; audit readiness.
• Prepare for sponsor audits and regulatory inspections.
• Mentor and develop EPCM staff and leadership.
• Collaborate with senior leadership and cross-functional teams.

Skills

Communication skills

Interpersonal skills

Project management

Emotional intelligence

Data interpretation

Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Manager, Early Phase Risk & Compliance (On-site 2 - 3 days)

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart.

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 environmen