Amendment Implementation Specialist

4 weeks ago

New York, New York, United States Thermo Fisher Scientific Full time
Job Description

At Thermo Fisher Scientific, we're committed to enabling our customers to make the world healthier, cleaner, and safer. As an Amendment Implementation Specialist, you'll play a critical role in supporting our customers in achieving their goals.

Key Responsibilities
  • Support the amendment implementation strategy at country and site levels, within a region or globally
  • Support understanding of amendment scope, classification, and timelines
  • Support requests of country resources in Clarity
  • Collaborate with the project team on amendment planning
  • Discuss financial coverage for the amendment with the Project Lead
  • Track amendment-related actions and facilitate updates within applicable system(s)
  • Schedule and conduct progress check calls with local teams
  • Update Principal Investigator Amendment Notification and Amendment Implementation Letters
  • Liaise with the Regulatory Affairs Lead and project team to assess amendment submission requirements and country submission timelines
  • Update forecasting and actuals for amendment-related units according to Clarity monthly deadlines
  • Inform project team members when amendment activities have been completed
  • Support risk identification and contingency planning pertaining to amendments
  • Introduction of roles and responsibilities to local team
  • Request access to study-related systems
Requirements
  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
  • Very good understanding of PSC tasks, applicable PSCs' and other manuals, eTMF, and File Review processes, client-specific manuals, procedures, and requirements
  • Audit/inspection process awareness with relevant rules and guidance documents
  • Expert knowledge of an application (e.g., Excel), 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 several MS Office (Word, Excel, PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
  • Strong collaborators, very good communication skills, capable to shift prioritization according to project needs and timelines
  • Ability to work in a team or independently as required
  • Good negotiation skills
  • Must be able to multi-task
  • Exposure to high pressure
  • Attention to details
Physical Requirements/Work Environment
  • Work is performed in an office environment with exposure to electrical office equipment
  • May be required to work different shifts
  • Long, varied hours required on occasions
  • Potential occasional travel required
  • Frequently stationary for 6-8 hours per day
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
  • Frequent mobility required
  • Occasional crouching, stooping, bending, and twisting of upper body and neck
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
  • Frequently interacts with others to obtain or relate information to diverse groups
  • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

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.

Apply today

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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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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