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Amendment Implementation Specialist
hace 1 mes
At Thermo Fisher Scientific, we are seeking a highly skilled Amendment Implementation Specialist to join our team. As an Amendment Implementation Specialist, you will play a critical role in ensuring the successful implementation of amendments within assigned projects. Your primary responsibility will be to complete amendment activities, ensuring that deliverables meet customer expectations and contracted milestones.
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.
- 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 systems.
- 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 teams.
- Request access to study-related systems.
- 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.
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.
