Amendment Implementation Specialist
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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:
Bachelor's 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
Apply To This Job
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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:
Bachelor's 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
Apply To This Job