Amendment Implementation Specialist
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Job Location:
Monthly Salary:
Posted on:
13 days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Amendment Implementation Specialist
Summarized Purpose:Completes amendment activities within assigned projects and ensures amendment deliverables meet customer expectations as well as contracted milestones by providing accurate projections report updates and ongoing risk assessments.
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:
- Bachelors 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
Required Experience:
IC
Key Skills
- Employee Orientation
- Dayforce
- Human Capital Management
- Visio
- Business Process Modeling
- Process Mapping
- Ceridian
- Smartsheet
- Salesforce
- Peoplesoft
- Project Management
- Microsoft Project
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
