Work Schedule

Environmental Conditions

Job Description

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

• 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.
• Plan, monitor, and report on quality and compliance for selected clinical trial delivery processes to determine adherence to and understanding of ICH GCP requirements.
• Facilitate and manage cross-functional teams’ GCP inspection readiness and execution activities throughout the study lifecycle
• Embed real-time inspection readiness strategies into daily operations in collaboration with study teams, aligned with Global Development Compliance and Clinical Quality Assurance.
• Ensure high-quality deliverables for global studies or programs by guiding study teams on adherence to operational processes and well-prepared documentation
• Develop and maintain metrics, charts, and dashboards to track process quality and compliance.
• Provide near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes.

Requirements

• Bachelor’s degree preferred
• Regulatory Authority Inspections Experience (FDA, MHRA, HEALTH CANAD, EMEA, etc.)
• Experience leading cross-functional teams through the inspection readiness process and the inspections themselves.
• Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field
• Solid knowledge of and experience in GCP compliance, regulatory inspection readiness and study execution processes
• Experience with CROs and outsourced clinical trial activities, sponsor experience, must have worked within a GCP environment
• Solid knowledge of drug development and clinical trial processes, including related standards and documents.
• Experience in clinical trials systems management and oversight (Veeva preferred)
• Proven awareness of sponsor oversight requirements and regulations
• Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
• Strong project management and communications skills to effectively assess risks, establish priorities, take initiative, and meet deadlines
• Must be able to work in a fast-paced, changing environment with demonstrated ability to prioritize multiple competing tasks and demands
• Solid knowledge of regulatory requirements governing clinical trials and industry best practices

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Work Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to build a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully while prioritising multiple projects or activities.
• May require travel. (TA will provide more details if necessary)

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.