Associate Clinical Compliance Director

Summary/Job Purpose

The Associate Clinical Compliance Director ensures risk management, issue management, and risk/issue monitoring are implemented and embedded across their responsible trial portfolio and functional areas of focus. Ensures clinical research activities are conducted by clinical staff in accordance with ICH GCP, relevant international and local regulations, requirements, and guidelines. Partners with quality assurance (QA) teams and other functional groups across PDMA to execute inspection readiness, risk management, oversight of quality performance metrics, and issue escalation of quality issues. The Associate Director provides Good Clinical Practice (GCP) guidance and best-practice expertise to facilitate optimal clinical trial execution compliance management as it relates to Process Deviations and CAPA management to ensure study adherence to applicable GCP regulations throughout all phases of clinical development.

Essential Duties And Responsibilities

As part of Clinical Compliance and Risk Management (CCRM) Team, represent Development Operations and collaborate with Quality Assurance on compliance-related activities, processes and functions.

• Support Development Operations functions and Clinical Study Delivery Teams to maintain readiness, prepare for, and participate in regulatory agency inspections and Quality audits.
• Create and manage the training curriculum for the Development Operations Organization, so every active employee is fully trained on GCP/ICH guidance and regulations through hands-on training and SOP/WI implementation.
• Display active leadership as it relates to Development Operations management of process deviations, audit and inspection findings, and CAPAs.
• Manage and track Development Operations internal and external audit responses. Support input and the review of investigator, vendor, process and system audits to ensure responses are complete and provided in a timely manner.
• Manage and track Development Operations and Vendor assigned CAPAs validation, processing and resolution to ensure on-time closure. Translate and facilitate with functional area partners an outcome to defined process, study plans or training updates.
• Ensure inspection readiness, review periodically the outcomes of risk management/management monitoring; escalate to appropriate governance and adapt accordingly.
• Collaborate with cross-functional teams to identify compliance program risks