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 monitoringMinimum of 4+ years clinical research experience in pharmaceutical or biotechnology fieldSolid knowledge of drug development, clinical trial management, and/or GCP compliance processesProven track record of strong project management skills and experience managing clinical trial delivery activities for drug development programsExperience in problem solving, negotiations, and collaborative team building with non- direct reports and other stakeholders is requiredSolid knowledge of regulatory requirements governing clinical trials, industry best practices, and related standard and documentation requirementsBS, MS, or equivalent in scientific fieldMust be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management, and presentationsCan effectively resolve conflict in a constructive mannerValid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travelDomestic/international travel (5-20%) may be requiredModerate supervision required, should be able to function collaboratively with all levels of employees