Director, Clinical Operations Compliance, GCP

Role Overview

• Identifying and anticipating potential issues impacting business goals
• Leading global initiatives and working groups
• Collaborating with study teams to ensure quality compliance
• Designing study documents to ensure quality by design
• Developing risk identification and management strategies
• Consulting on business initiatives and tools for compliance
• Maintaining expertise in global GCP guidance and regulations
• Conducting quality issue trending and root cause analysis

Requirements

• Impeccable ethics
• Sound judgement and discretion
• Demonstrated experience with planning and prioritizing
• Strong organizational skills
• Knowledgeable in stakeholder management
• Proven interpersonal skills
• Knowledge of evolving legal and regulatory environment
• Understanding of corporate and organizational policies

Tech Stack

• Google Cloud Platform

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness