Sr Amendment Implementation Specialist

JOB DESCRIPTION

Work Schedule

Environmental Conditions

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 the 
  effective 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