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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

+ 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.

+ 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

+ 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 3+ 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 leading clinical trial delivery activities for drug development programs.

+ Experience in problem solving, negotiations, and collaborative team building with non-direct reports and other collaborators is required.

+ Solid understanding of regulatory requirements that govern clinical trials, industry standards, and related documentation needs.

+ BS, MS, or equivalent in scientific field.

+ Must be able to efficiently use computer software programs like Microsoft Office for general tasks, 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.

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.