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
