Director, Clinical Operations Compliance, GCP
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Job Description
Director of Clinical Operations Compliance managing GCP regulations for global clinical trials. Ensuring compliance and quality across initiatives in a remote setting.
Responsibilities:
- 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
Benefits:
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
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