Amendment Implementation Specialist
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Job Location:
Mexico City - Mexico
Monthly Salary:
Not Disclosed
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.
Essential Functions:
- Supports the amendment implementation strategy at country and site levels within a region or globally
- Supports understanding of amendment scope classification and timelines
- Supports requests of country resources in Clarity
- Collaborates with project teams on amendment planning
- Discusses financial coverage for an amendment with the Project Lead
- Tracks amendment related actions and facilitates updates within applicable system(s)
- Schedules and conducts progress check calls with project teams
- Updates Principal Investigator Amendment Notification and Amendment Implementation Letters
- Liaises with the Regulatory Affairs Leads and project teams to assess amendment submission requirements and country submission timelines
- Prepares and distributes the Amendment Progress Report and other applicable study reports to project teams to act on compliance gaps as applicable directly in systems providing a deadline for feedback
- Updates forecasting and actuals for amendment related units according to Clarity monthly deadlines
- Informs project team members when amendment activities have been completed
- Supports risk identification and contingency planning pertaining to amendments
- Introduces roles and responsibilities to project team
- Requests access to study related systems
Education & Experience:
- Bachelors degree or equivalent and relevant formal academic/vocational qualification
- Previous experience that provides the knowledge skills and abilities to perform the job
Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Why join us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.
Apply today to help us deliver tomorrows breakthroughs.
Required Experience:
IC
Key Skills
- Employee Orientation
- Dayforce
- Human Capital Management
- Visio
- Business Process Modeling
- Process Mapping
- Ceridian
- Smartsheet
- Salesforce
- Peoplesoft
- Project Management
- Microsoft Project
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
