Senior Manager, Early Phase Risk & Compliance

Parexel International; Glendale (CA); Hybrid; USD 120,000 - 140,000; Full time

Benefits offered by this job

Health, Vision & Dental Insurance

Tuition Reimbursement

Vacation/Holiday/Sick Time

401(k) with Company match

Pet Insurance

Job summary

Parexel International is seeking a Manager, Early Phase Risk and Compliance for a hybrid role in Glendale, CA. You will lead Risk and Compliance Leads, drive risk assessments, and ensure regulatory compliance across EPCUs while partnering with QA and client teams.

Strong leadership, project management, and ICH-GxP expertise are essential. You will mentor staff, oversee audits, and help advance Parexel's quality programs within a collaborative, multi-disciplinary environment.

Qualifications

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

Responsibilities

• Lead and manage Risk and Compliance Leads supporting EPCUs
• Oversee risk management initiatives and mitigating actions across trials
• Ensure compliance with Parexel SOPs, regulatory requirements, and training curricula
• Coordinate readiness for inspections and sponsor audits; partner with QA for internal audits
• Engage with clients as ARCL where assigned and manage client-level risk and quality agreements
• Attract, recruit, and develop EPRCM staff; provide feedback and training
• Identify opportunities to enhance QMS and risk management through reviews

Skills

Communication

Leadership

Project management

Data interpretation

Adaptability

Attention to detail

Matrix environment

Travel up to 10%

Education

Bachelor's Degree in life science

Master's Degree in science/related field

Job description

Parexel International is seeking a Manager, Early Phase Risk and Compliance for a hybrid role in Glendale, CA. You will lead Risk and Compliance Leads, drive risk assessments, and ensure regulatory compliance across EPCUs while partnering with QA and client teams.

Strong leadership, project management, and ICH-GxP expertise are essential. You will mentor staff, oversee audits, and help advance Parexel's quality programs within a collaborative, multi-disciplinary environment.