Amendment Implementation Specialist

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

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

Working Environment: Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Why join us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.