Amendment Implementation Specialist

5 days ago

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

Description

• The Amendment Implementation Specialist completes amendment activities within assigned projects • Ensures amendment deliverables meet customer expectations and contracted milestones • Provides accurate projections, report updates, and ongoing risk assessments • Supports the amendment implementation strategy at country and site levels • Collaborates with the project team on amendment planning • Tracks amendment related actions and facilitates updates within applicable systems • Schedules and conducts progress check calls with local teams • Supports risk identification and contingency planning pertaining to amendments • Updates forecasting and actuals for amendment related units according to Clarity monthly deadlines

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 • 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 • 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, Power Point) • Strong collaborators, very good communication skills • Ability to work in a team or independently • Good negotiation skills • Must be able to multi-task • Exposure to high pressure • Attention to details

Benefits

• We offer competitive remuneration • Annual incentive plan bonus • Healthcare • A range of employee benefits