Manager, Early Phase Risk & Compliance

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds 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 were 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 22000 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). Youll 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

Youll 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

Bachelors Degree in life science or health-related discipline

Masters Degree in a science technology or industry-related discipline

Benefits and Compensation

Health Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

Flexible Spending & Health Savings Accounts

Work/Life Balance

401(k) with Company match

Pet Insurance

For a complete list of benefits please visit potential base pay range for this role is $120K - $140K. The actual salary offered may vary within this range based on several factors including the position and level offered skills education training experience professional achievements and location.

Some roles may also be eligible for additional incentives bonuses or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

We offer a comprehensive benefits package to eligible employees which includes paid time off a 401(k) match life insurance health insurance and additional benefit offerings in accordance with the terms of our applicable plans.

If this job doesnt sound like the next step in your career but perhaps you know of someone whod be a perfect fit send them the link to apply!

We believe in flexibility growth and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status which in the US includes race color religion sex sexual orientation gender identity national origin disability or protected veteran status.