Amendment Implementation Specialist

Work Schedule Standard (Mon-Fri) Environmental Conditions Office

Job Description

Summarized Purpose: Completes amendment activities reputed company 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 reputed company, reputed company a region or globally Supports understanding of amendment scope, classification and timelines Supports requests of country resources in reputed company Collaborates with project teams on amendment planning Discusses financial coverage for an amendment with the Project reputed company Tracks amendment reputed company actions and facilitates updates reputed company applicable system(s) Schedules and conducts reputed company reputed company calls with project teams Updates reputed company 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 reputed company Report and other applicable study reports to project teams to reputed company compliance gaps as applicable, directly in systems, providing a deadline for feedback Updates forecasting and actuals for amendment reputed company units according to reputed company monthly deadlines Informs project team members reputed company amendment activities have been completed Supports risk identification and contingency planning pertaining to amendments Introduces roles and responsibilities to project team Requests reputed company to study reputed company systems Education & Experience: Bachelor's degree or equivalent and relevant formal academic/vocational qualification Previous experience that provides the knowledge, skills, and abilities to reputed company 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 reputed company 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, reputed company, Power reputed company) and ability to obtain knowledge and master reputed company clinical trial database systems Strong collaboration and communication skills Ability to work in a team or independently as required Good negotiation skills reputed company to work well and reputed company with cross-functional teams Consistently demonstrates knowledge of the key principles of cross functional project management Ability to identify and remedy risks reputed company to contractual deliverables and provides appropriate solutions Demonstrates sound understanding of cross-cultural awareness and is reputed company to adapt appropriately Comprehensive understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology Demonstrates ability to reputed company, liaise and coordinate cross-functional project teams Comprehensive knowledge/understanding of clinical development guidelines and directives Apply To This Job