GCP Compliance Oversight Manager FSP
GCP Compliance Oversight Manager FSP
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1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
Join Thermo Fisher Scientific Inc. as an outstanding GCP Compliance Oversight Manager and play a crucial role in ensuring the flawless of clinical trials. This is an outstanding opportunity to work in a worldclass healthcare environment where your expertise will contribute to groundbreaking scientific advancements.
Job Responsibilities
- Plan monitor and report on quality and compliance for selected clinical trial delivery processes to determine adherence and understanding of ICH GCP requirements.
- Provide projectlevel QA support collaborating with internal and external teams.
- Perform proactive and routine evaluations of clinical trial processes to ensure adherence to procedural documentation through detailed documentation review and active engagement with study team functional representatives.
- Promote awareness of quality and regulatory compliance standards and trends; participate in quality improvement activities.
- Develop and maintain metrics charts and dashboards to track process quality and compliance.
- Coordinate governance and compliance management processes; implement quality awareness objectives; develop and maintain quality and compliance mentorship/reference materials and tools.
- Provide near realtime feedback on study process and documentation quality as well as team performance and understanding on evaluated processes.
- Ensure compliance with personal learning requirements.
- Perform other duties as assigned.
Requirements
- Good understanding of clinical trial processes related to sponsor and CRO activities including but not limited to sponsor oversight issue management site management and clinical monitoring
- Minimum of 4 years clinical research experience in pharmaceutical or biotechnology field
- Solid knowledge of drug development clinical trial management and/or GCP compliance processes
- Proven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programs
- Experience in problem solving negotiations and collaborative team building with non direct reports and other stakeholders is required
- Solid knowledge of regulatory requirements governing clinical trials industry best practices and related standard and documentation requirements
- BS MS or equivalent in scientific field
- Must be able to efficiently utilize computer software programs such as Microsoft Office for general use project management and presentations
- Can effectively resolve conflict in a constructive manner
- Valid drivers license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
- Domestic/international travel 520 may be required
- Moderate supervision required should be able to function collaboratively with all levels of employees
Required Experience:
Manager
Employment Type
Full-Time
