GCP Compliance Oversight Manager

March 7

🌲 North Carolina – Remote

Although this job is listed in North Carolina, this company may be open to hiring remote in other states.

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Thermo Fisher Scientific

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Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 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. • 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