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Amendment Implementation Specialist

Thermo Fisher Scientific

Amendment Implementation Specialist

full-timePosted: Jan 12, 2026

Job Description

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

Locations

  • Global

Salary

Estimated Salary Rangemedium confidence

50,000 - 90,000 USD / yearly

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • amendment implementationintermediate
  • audit/inspection awarenessintermediate
  • organizational skillsintermediate
  • analytical skillsintermediate
  • ICH GCP knowledgeintermediate
  • MS Office proficiencyintermediate
  • negotiationintermediate
  • collaborationintermediate

Required Qualifications

  • Bachelor's degree or equivalent (experience)
  • previous amendment management experience (experience)

Responsibilities

  • support amendment strategy at country/site levels
  • collaborate on amendment planning
  • track actions and updates
  • liaise with Regulatory Affairs
  • prepare/distribute reports
  • update forecasting/actuals
  • support risk identification

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Thermo Fisher Scientific logo

Amendment Implementation Specialist

Thermo Fisher Scientific

Amendment Implementation Specialist

full-timePosted: Jan 12, 2026

Job Description

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

Locations

  • Global

Salary

Estimated Salary Rangemedium confidence

50,000 - 90,000 USD / yearly

* This is an estimated range based on market data and may vary based on experience and qualifications.

Skills Required

  • amendment implementationintermediate
  • audit/inspection awarenessintermediate
  • organizational skillsintermediate
  • analytical skillsintermediate
  • ICH GCP knowledgeintermediate
  • MS Office proficiencyintermediate
  • negotiationintermediate
  • collaborationintermediate

Required Qualifications

  • Bachelor's degree or equivalent (experience)
  • previous amendment management experience (experience)

Responsibilities

  • support amendment strategy at country/site levels
  • collaborate on amendment planning
  • track actions and updates
  • liaise with Regulatory Affairs
  • prepare/distribute reports
  • update forecasting/actuals
  • support risk identification

Target Your Resume for "Amendment Implementation Specialist" , Thermo Fisher Scientific

Get personalized recommendations to optimize your resume specifically for Amendment Implementation Specialist. Takes only 15 seconds!

AI-powered keyword optimization
Skills matching & gap analysis
Experience alignment suggestions

Check Your ATS Score for "Amendment Implementation Specialist" , Thermo Fisher Scientific

Find out how well your resume matches this job's requirements. Get comprehensive analysis including ATS compatibility, keyword matching, skill gaps, and personalized recommendations.

ATS compatibility check
Keyword optimization analysis
Skill matching & gap identification
Format & readability score
Quiz Challenge

Answer 10 quick questions to check your fit for Amendment Implementation Specialist @ Thermo Fisher Scientific.

10 Questions
~2 Minutes
Instant Score

Related Books and Jobs

No related jobs found at the moment.