Sr Amendment Implementation Specialist
4 semanas atrás
About the Role:
The Sr Amendment Implementation Specialist plays a critical role in ensuring the successful implementation of amendments within assigned projects. This involves providing accurate projections, report updates, and ongoing risk assessments to meet customer expectations and contracted milestones.
Key Responsibilities:
- Supports the amendment implementation strategy at country and site levels.
- Understands amendment scope, classification, timelines, and whether participant safety is affected.
- Oversees 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 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.
- Performs risk identification and contingency planning pertaining to amendments.
- Introduction of roles and responsibilities to local team.
- Request access to study related systems.
Requirements:
- Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
What We Offer:
Thermo Fisher Scientific offers competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. We provide an innovative, forward-thinking organization, and outstanding career and development prospects. Our company culture stands for integrity, intensity, involvement, and innovation.
Why Work with Us:
At Thermo Fisher Scientific, we enable our customers to make the world healthier, cleaner, and safer. 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.
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