Amendment Implementation Specialist

Description

**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