Clinical Compliance Manager
Welcome to PPD-Pharmaceutical Product Development, a global contract research organization dedicated to helping our clients bring life-changing drugs to market. We are currently seeking a highly skilled and experienced Clinical Compliance Manager to join our team. In this role, you will play a crucial role in ensuring that all clinical trials are conducted in compliance with applicable regulations and standards. If you have a passion for ensuring patient safety and data integrity, and possess a strong understanding of clinical research compliance requirements, we would love to hear from you.
- Develop and maintain a thorough understanding of all applicable regulations and standards related to clinical research compliance.
- Collaborate with cross-functional teams to ensure all clinical trials are conducted in compliance with applicable regulations and standards.
- Identify potential compliance risks and develop plans to mitigate them.
- Conduct internal audits to assess compliance with regulations and standards.
- Develop and implement training programs for staff on compliance requirements and best practices.
- Serve as a subject matter expert on compliance-related matters and provide guidance to project teams.
- Monitor and track compliance metrics and report on any issues or trends to management.
- Stay up-to-date on changes to regulations and standards and communicate any updates to relevant teams.
- Conduct regular reviews of study documents to ensure compliance with regulatory requirements.
- Participate in external audits and inspections and coordinate responses to findings.
- Collaborate with Quality Assurance and Risk Management teams to develop and implement corrective and preventative actions.
- Serve as the main point of contact for compliance-related inquiries from internal and external stakeholders.
- Continuously evaluate and improve processes and procedures related to clinical research compliance.
- Represent the organization in compliance-related meetings and trainings.
- Maintain accurate and organized documentation of all compliance-related activities.
Excellent Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And External Stakeholders.
Bachelor's Degree In A Relevant Field Such As Healthcare Administration, Life Sciences, Or Regulatory Affairs.
Minimum Of 5 Years Of Experience In Clinical Compliance, Preferably In A Pharmaceutical Or Biotechnology Company.
In-Depth Knowledge Of Fda Regulations, Ich Guidelines, And Gcp Standards.
Strong Understanding Of Clinical Trial Processes And Procedures, Including Protocol Development, Data Management, And Reporting.
Risk Management
Quality Assurance
Communication Skills
Project Management
Data Analysis
Auditing
Regulatory compliance
Training And Education
Gcp (Good Clinical Practice)
Sop (Standard Operating Procedure) Development
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Clinical Compliance Manager is $81,000 - $107,000 per year. This can vary depending on factors such as location, experience, and specific job duties. Some Clinical Compliance Managers may earn more or less than this range.
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PPD, Inc. is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.
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