SR Amendment Implementation Specialist
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
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:Collaborates with multiple team members in a matrix environment for theeffective delivery of site activation within the assigned projects.
- May oversee site activation for assigned projects according to timelines and quality standard.
- Assists with coordination of the flow of information between PPD teams, clients, or functional departments involved in site activation.
- Develops recommended plans/guidelines for project implementation using PPD tools
- Monitors and analyzes project status to ensure successful progress and completion of all assigned projects and provide metrics to upper management.
- Performs risk identification and provides contingency planning.
- Collaborates with PPD teams to manage all financial and contractual aspects of the studies related to site activation.
- Works within the team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets with accountability to Global Project Management.
- Administers the technical and operational aspects of the site activation portion of the assigned projects, including coordination of feasibility, site contracts, and country teams in a matrix environment and manages the assigned scope of work against timelines, costs, and quality.
- Participates with functional area leads to identify and evaluate fundamental issues pertaining to successful site activation, interpret data on complex issues, make good business decisions and ensure solutions are implemented.
- Develops customer relationships in alignment with assigned projects
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 (comparable to 5+ years’)
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
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