Thermo Fisher Scientific logo
Thermo Fisher Scientific

Thermo Fisher Scientific is a global biotechnology product development company whose mission is to make the world healthier, cleaner, and safer. Thermo Fisher Scientific leads a gl

Amendment Implementation Specialist

Location

Brazil

Posted

17 days ago

Salary

0

Seniority

Senior

No structured requirement data.

Job Description

Amendment Implementation Specialist

Thermo Fisher Scientific

Title: Amendment Implementation Specialist Location: Remote São Paulo Brazil Full time Remote   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   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

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