GCP Compliance Oversight Manager, FSP

Position Overview

• Location Type: Onsite
• Job Type: Full time
• Salary: Not provided
• Join Thermo Fisher Scientific Inc. as a 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.

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

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.

Application Instructions

• Not provided

Company Information

• Thermo Fisher Scientific Inc.