GCP Compliance Oversight Manager, FSP

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The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.

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JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Thermo Fisher Scientific Inc. as an outstanding GCP Compliance Oversight Manager and play a crucial role in ensuring the flawless execution of clinical trials. This is an outstanding opportunity to work in a world-class 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 project-level 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 real-time 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 driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
Domestic/international travel (5-20%) may be required
Moderate supervision required, should be able to function collaboratively with all levels of employees