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 vendorsPrioritize & respond to urgent quality requests within team or from sponsorServe 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 managementWork 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 classificationFacilitate root cause analysis (RCA) meeting & provide guidance on RCA process using various methodologiesFacilitate the initial assessment of Serious Breach of GCPResponsible for development of robust corrective & preventive actions (CAPA)

Inspection Readiness

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

Quality Consultancy

Provide real-time quality advice to support project teams in delivering first-time qualityReview 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 projectsReview/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 principlesAbility 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 preferredMaster's degree in a science, technology or industry-related discipline preferred

EEO Disclaimer

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