*work schedule*
standard (mon-fri)
*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 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
- 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