Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Amendment Implementation Specialist / Senior Implementation Specialist

Remote based - Serbia OR Bulgaria

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.

• 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

• Bachelor's degree or equivalent and relevant formal academic/vocational qualificatio

• 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

• Work is performed in an office environment with exposure to electrical office equipment.
• May be required to work different shifts
• Long, varied hours required on occasions
• Potential occasional travel required
• Frequently stationary for 6-8 hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
• Frequent mobility required
• Occasional crouching, stooping, bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence