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Urgent! Amendment Implementation Specialist Job Opening In Remote – Now Hiring ThermoFisher Scientific
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Job Description
**Amendment Implementation Specialist**
**Summarized Purpose:** Completes amendment activities within assigned projects and ensures amendment deliverables meet customer expectations, as well as contracted milestones by providing accurate projections, report updates, and ongoing risk assessments.
**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:**
+ Bachelor's degree or equivalent and relevant formal academic/vocational qualification
+ Previous experience that provides the knowledge, skills, and abilities to perform the job
+ Previous experience with managing amendment is essential
**Knowledge, Skills and Abilities**
+ Audit/inspection process awareness of relevant rules and guidance documents
+ Expert knowledge of an application, system or process
+ Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively
+ Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
+ Analytical skills, ability to comprehend and analyze data, tables, etc.
+ Strong customer focus
+ Flexibility to reprioritize workload to meet changing project timelines
+ Knowledge of ICH GCP, strong comprehension of applicable SOPs, good understanding of a clinical trial life cycle
+ Advanced English (verbal & written)
+ Good computer skills, proficient in MS Office (Word, Excel, Power Point) and ability to obtain knowledge and master all clinical trial database systems
+ Strong collaboration and communication skills
+ Ability to work in a team or independently as required
+ Good negotiation skills
+ Able to work well and efficiently with cross-functional teams
+ Consistently demonstrates knowledge of the key principles of cross functional project management
+ Ability to identify and remedy risks related to contractual deliverables and provides appropriate solutions
+ Demonstrates sound understanding of cross-cultural awareness and is able to adapt appropriately
+ Comprehensive understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology
+ Demonstrates ability to lead, liaise and coordinate cross-functional project teams
+ Comprehensive knowledge/understanding of clinical development guidelines and directives
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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Unlock Your Amendment Implementation Potential: Insight & Career Growth Guide
Real-time Amendment Implementation Jobs Trends in Remote, Colombia (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Amendment Implementation in Remote, Colombia using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 132 jobs in Colombia and 2 jobs in Remote. This comprehensive analysis highlights market share and opportunities for professionals in Amendment Implementation roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! ThermoFisher Scientific is currently hiring and seeking a Amendment Implementation Specialist to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Amendment Implementation Specialist Jobs Remote.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at ThermoFisher Scientific adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Amendment Implementation Specialist Jobs Colombia varies, but the pay scale is rated "Standard" in Remote. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
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Before the Interview:To prepare for your Amendment Implementation Specialist interview at ThermoFisher Scientific, research the company, understand the job requirements, and practice common interview questions.
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