Sr Amendment Implementation Specialist

Work Schedule Standard (Mon-Fri)
Environmental Conditions Office
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.
Discover Impactful Work: The Sr 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.
A Day in the Life: Supports the amendment implementation strategy at country and site levelsUnderstands amendment scope, classification, timelines, and whether participant safety is affectedOversees requests of country resources in ClarityCollaborates with the project team on amendment planningDiscusses financial coverage for the amendment with the Project LeadTracks amendment related actions and facilitates updates within applicable system(s)Schedules and conducts progress check calls with local teamsUpdates Principal Investigator Amendment Notification and Implementation LettersLiaises with the Regulatory Affairs Lead and project team to assess amendment submission requirements and country submission timelinesUpdates forecasting and actuals for amendment related units according to Clarity monthly deadlinesInforms project team members when amendment activities have been completedPerforms risk identification and contingency planning pertaining to amendmentsIntroduction of roles and responsibilities to local teamRequest access to study related systemsKeys to Success: Education: Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
Knowledge, Skills, Abilities: Very good understanding of PSC tasks, applicable PSCs' and other manuals, eTMF and File Review processes, client-specific manuals, procedures and requirementsAudit/inspection process awareness with relevant rules and guidance documentsExpert knowledge of an application (e.g. Excel), system or processGood organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectivelyAbility to effectively analyze project-specific data/systems to ensure accuracy and efficiencyAnalytical skills, ability to comprehend and analyze data, tables, etc.Strong customer focusFlexibility to reprioritize workload to meet changing project timelinesKnowledge of ICH GCP, strong comprehension of applicable SOPs, good understanding of a clinical trial life cycleAdvanced 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 systemsStrong collaborators, very good interpersonal skills, capable to shift prioritization according to project needs and timelinesAbility to work in a team or independently as requiredGood negotiation skillsAbility to work under pressurePhysical Requirements / Work Environment: 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.Exposure to high pressure.Frequent interaction with project teams/clients/vendors.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.Regular and consistent attendance.Benefits: 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. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
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