GCP Compliance Oversight Manager
Are you a detail-oriented and organized individual with a strong understanding of GCP compliance regulations? Do you thrive in a fast-paced and dynamic work environment? Thermo Fisher Scientific is seeking a highly skilled GCP Compliance Oversight Manager to join our team. As a global leader in the life sciences industry, we are committed to maintaining the highest standards of ethical and regulatory compliance. In this role, you will be responsible for overseeing all aspects of GCP compliance for our clinical research projects. We are looking for an individual with extensive experience in GCP compliance and a passion for upholding industry standards. If you are ready to take on a challenging and rewarding role, we welcome you to apply for this position.
- Develop and maintain a comprehensive understanding of GCP compliance regulations and industry standards.
- Oversee all aspects of GCP compliance for clinical research projects, including protocol design, data collection and management, and investigational product handling.
- Review and approve clinical study protocols, informed consent forms, and other essential documents to ensure compliance with GCP regulations.
- Conduct regular audits and inspections to identify any potential areas of non-compliance and develop corrective action plans.
- Collaborate with cross-functional teams to ensure GCP compliance is integrated into all clinical research activities.
- Develop and implement GCP training programs for employees and study personnel.
- Stay informed about changes in GCP regulations and industry standards and proactively update company policies and procedures.
- Serve as the primary point of contact for regulatory agencies during inspections and audits related to GCP compliance.
- Maintain accurate and up-to-date records of all GCP compliance activities.
- Train and mentor team members on GCP compliance and provide guidance and support as needed.
- Communicate effectively with internal and external stakeholders regarding GCP compliance issues and initiatives.
- Identify and recommend opportunities for process improvement to ensure ongoing GCP compliance and efficiency.
- Represent the company at industry conferences and events related to GCP compliance.
- Act as a subject matter expert and provide guidance to project teams and other departments on GCP compliance matters.
- Uphold the company's commitment to ethical and regulatory compliance at all times.
Strong Understanding Of Gcp Regulations: A Successful Gcp Compliance Oversight Manager Should Have A Deep Understanding Of Good Clinical Practice (Gcp) Regulations And Guidelines, Including Ich (International Council For Harmonisation) And Fda Regulations.
Experience In Clinical Trial Oversight: Thermo Fisher Scientific Requires A Gcp Compliance Oversight Manager With Experience In Clinical Trial Oversight, Including Conducting Audits, Monitoring Compliance, And Implementing Corrective Actions.
Excellent Communication And Interpersonal Skills: The Gcp Compliance Oversight Manager Will Be Responsible For Communicating With Various Stakeholders, Including Internal Teams, Clients, And Regulatory Agencies. Therefore, Strong Communication And Interpersonal Skills Are Essential For This Role.
Attention To Detail And Analytical Skills: As A Gcp Compliance Oversight Manager, One Must Have A Keen Eye For Detail And Possess Excellent Analytical Skills To Identify Potential Compliance Issues And Develop Effective Solutions.
Project Management Skills: Thermo Fisher Scientific Is A Global Company With Multiple Ongoing Clinical Trials. The Ideal Candidate Should Have Excellent Project Management Skills To Manage And Prioritize Tasks, Meet Deadlines, And Handle Multiple Projects Simultaneously.
Risk Management
Quality Assurance
Process Improvement
Communication Skills
Project Management
Vendor Management
Data Analysis
Team Leadership
Regulatory compliance
Training Development
Audit Coordination
Sop Implementation
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Organization
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a GCP Compliance Oversight Manager is $90,000 to $120,000 per year. However, this can vary depending on factors such as location, experience, and the specific company and industry.
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Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.
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