Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Office

Job Description

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 globallySupports understanding of amendment scope, classification and timelinesSupports requests of country resources in ClarityCollaborates with project teams on amendment planningDiscusses financial coverage for an amendment with the Project LeadTracks amendment related actions and facilitates updates within applicable system(s)Schedules and conducts progress check calls with project teamsUpdates Principal Investigator Amendment Notification and Amendment Implementation LettersLiaises with the Regulatory Affairs Leads and project teams to assess amendment’ submission requirements and country submission timelinesPrepares 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 feedbackUpdates forecasting and actuals for amendment related units according to Clarity monthly deadlinesInforms project team members when amendment activities have been completedSupports risk identification and contingency planning pertaining to amendmentsIntroduces roles and responsibilities to project teamRequests access to study related systems

 Education & Experience:

Bachelor's degree or equivalent and relevant formal academic/vocational qualificationPrevious 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 documentsExpert knowledge of an application, system or process​Good organizational skills and strong attention to detail, with proven ability to handle multiple tasks efficiently and effectivelyAbility to effectively analyze project-specific data/systems to ensure accuracy and efficiencyAnalytical skills, ability to comprehend and analyze data, tables, etc.Strong customer focusFlexibility to reprioritize workload to meet changing project timelinesKnowledge of ICH GCP, strong comprehension of applicable SOPs, good understanding of a clinical trial life cycleAdvanced 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 systemsStrong collaboration and communication skillsAbility to work in a team or independently as requiredGood negotiation skillsAble to work well and efficiently with cross-functional teamsConsistently demonstrates knowledge of the key principles of cross functional project managementAbility to identify and remedy risks related to contractual deliverables and provides appropriate solutionsDemonstrates sound understanding of cross-cultural awareness and is able to adapt appropriatelyComprehensive understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminologyDemonstrates ability to lead, liaise and coordinate cross-functional project teamsComprehensive knowledge/understanding of clinical development guidelines and directives