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:

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job
• Previous experience with managing amendment is essential

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