Amendment Implementation Specialist

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p><b>Summarized Purpose:</b> 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.</p><p><b>Essential Functions: </b></p><ul><li>Supports the amendment implementation strategy at country and site levels, within a region or globally</li><li>Supports understanding of amendment scope, classification and timelines</li><li>Supports requests of country resources in Clarity</li><li>Collaborates with project teams on amendment planning</li><li>Discusses financial coverage for an amendment with the Project Lead</li><li>Tracks amendment related actions and facilitates updates within applicable system(s)</li><li>Schedules and conducts progress check calls with project teams</li><li>Updates Principal Investigator Amendment Notification and Amendment Implementation Letters</li><li>Liaises with the Regulatory Affairs Leads and project teams to assess amendment’ submission requirements and country submission timelines</li><li>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</li><li>Updates forecasting and actuals for amendment related units according to Clarity monthly deadlines</li><li>Informs project team members when amendment activities have been completed</li><li>Supports risk identification and contingency planning pertaining to amendments</li><li>Introduces roles and responsibilities to project team</li><li>Requests access to study related systems</li></ul><p></p><p> <b>Education &amp; Experience:</b></p><ul><li>Bachelor&#39;s degree or equivalent and relevant formal academic/vocational qualification</li><li>Previous experience that provides the knowledge, skills, and abilities to perform the job</li></ul><p></p><p><b>Knowledge, Skills and Abilities</b></p><ul><li>Audit/inspection process awareness of relevant rules and guidance documents</li><li>Expert knowledge of an application, system or process​</li><li>Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectively</li><li>Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency</li><li>Analytical skills, ability to comprehend and analyze data, tables, etc.</li><li>Strong customer focus</li><li>Flexibility to reprioritize workload to meet changing project timelines</li><li>Knowledge of ICH GCP, strong comprehension of applicable SOPs, good understanding of a clinical trial life cycle</li><li>Advanced English (verbal &amp; written)</li><li>Good computer skills, proficient in MS Office (Word, Excel, Power Point) and ability to obtain knowledge and master all clinical trial database systems</li><li>Strong collaboration and communication skills</li><li>Ability to work in a team or independently as required</li><li>Good negotiation skills</li><li>Able to work well and efficiently with cross-functional teams</li><li>Consistently demonstrates knowledge of the key principles of cross functional project management</li><li>Ability to identify and remedy risks related to contractual deliverables and provides appropriate solutions</li><li>Demonstrates sound understanding of cross-cultural awareness and is able to adapt appropriately</li><li>Comprehensive understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology</li><li>Demonstrates ability to lead, liaise and coordinate cross-functional project teams</li><li>Comprehensive knowledge/understanding of clinical development guidelines and directives</li></ul><p></p><p></p><p></p><p></p><p></p>