Sr. Compliance Manager - FSP (Remote - US)
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**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**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
I _n 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.
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.
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**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
I _n 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.
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.
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