Senior Amendment Implementation Specialist

4 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 the assigned projects and ensures amendment deliverables meet customer expectations, as well as contracted milestones by providing accurate projections, report updates, and ongoing risk assessments • 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 the project team on amendment planning • Discusses financial coverage for the amendment with the Project Lead • Tracks amendment related actions and facilitates updates within applicable system(s) • Schedules and conducts progress check calls with local teams • Updates Principal Investigator Amendment Notification and Amendment Implementation Letters • Liaises with the Regulatory Affairs Lead and project team to assess amendment submission requirements and country submission timelines • 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 • 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, Power Point) 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

Benefits

• competitive remuneration • annual incentive plan bonus • healthcare • a range of employee benefits