Job Information
ThermoFisher Scientific Amendment Implementation Specialist (Mid Shift/Fully Remote) in Remote, Philippines
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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 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 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
Keys 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 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
Physical 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
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
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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.