Glendale, CA (Hybrid role - office 3 days & 2 days remote based)

The Early Phase Risk & Compliance Lead II works closely with operational delivery teams to ensure compliance with regulatory requirements, client expectations, and internal policies through oversight of proactive risk management and quality support for clinical trials and Early Phase Clinical Units.

Reporting into the regional Manager, this role ensures first-time quality, robust risk and issue management and inspection readiness by collaborating with operational teams and clients. Key duties include facilitating risk assessments, managing quality events, supporting audits and inspections, and providing expert guidance on regulatory compliance. The position requires strong analytical, communication, and problem-solving skills, along with experience in clinical research, quality management, and ICH-GCP standards.

Key Responsibilities:

Client Liaison & Communication

• Effectively communicate with internal & external customers and third-party vendors
• Prioritize & respond to urgent quality requests within team or from sponsor
• Serve as point of contact for the client quality representatives for projects or accounts

Risk Management

• Leads, facilitates and supports risk identification and mitigation processes.
• Facilitates robust project-level risk management
• Work with operational teams, functional leads and SME's to identify, categorize, score risks and develop risk mitigations

Quality Event Management

• Triage quality issues in electronic quality management systems (eQMS) ensuring appropriate severity classification
• Facilitate root cause analysis (RCA) meeting & provide guidance on RCA process using various methodologies
• Facilitate the initial assessment of Serious Breach of GCP
• Responsible for development of robust corrective & preventive actions (CAPA)

Inspection Readiness

• Support sponsor audit and/or inspection preparation
• Provide onsite or remote support for inspections as needed, representing Parexel Early Phase Risk & Compliance Management & speak to QMS when necessary
• Host sponsor audits remotely and on-site as requested

Quality Consultancy

• Provide real-time quality advice to support project teams in delivering first-time quality
• Review Parexel's internal documentation, SOP's, policies, and guidance materials to understand organizational expectation

Documentation & Storyboards

• Provide guidance on maintaining inspection-ready documentation for assigned projects
• Review/update storyboards as part of inspection preparation

Continuous Improvement

• Identify and propose process improvements.
• Participate in quality system enhancements.

Mentorship

• Mentor new RCL's as needed

Skills Required:

• 4+ years' experience in clinical research (GCP experience highly preferred)
• Strong communication and interpersonal skills.
• Critical thinking and analytical abilities.
• Experience with root cause analysis tools (e.g., 5 Whys, Fishbone).
• Advanced knowledge of ICH-GCP principles
• Ability to manage workload independently and in a matrix environment.

Education:

• Bachelor's Degree or other relevant experience as required. Life-science or other related health discipline preferred
• Master's degree in a science, technology or industry-related discipline preferred