Demanda en Irlanda de agente de centro de atención al cliente

Clinical Trial Associate fluent German

CTA role provides technical support to the clinical trial capabilities team in support of clinical development. The assistant is responsible for activities related to investigator sites readiness, maintenance and close out. The assistant will ensure inspection readiness through a complete, accurate and readily available Trial Master File. Additional country specific responsibilities may be required as needed/appropriate for the local geography and/or to cover regional differences.

Job Description

Initiate investigator site activities, including collection and submission of regulatory documents.

Track and ensure site compliance to effectively drive timelines aligned with company priorities

Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out

Support TPO and investigator payments as appropriate

Manage site account requests

Invoice query resolutions

Identify, communicate, and resolve issues

Accountable for accurate and complete data entry of clinical trial information into various clinical trial systems to allow tracking, performance metrics reporting and to meet regulatory compliance requirements.

Ensure appropriate archiving of documents to meet company record retention policies and regulatory requirements.

Ensure inspection readiness through a complete, accurate and readily available Trial Master File

Communicate directly with sites to enable start-up and maintain an active collaboration with sites during maintenance and close-out

Identify, communicate, and resolve issues

Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems

Leverage previous site / review board engagements to efficiently drive new work

Populate internal systems to ensure accuracy of trial / site performance

Understand and comply with procurements, legal and financial requirements and procedures

Populate Trial Master Files and libraries for future reference

Provide feedback and shared learning for continuous improvement

Leverage trial prioritization

Anticipate and monitor dynamically changing priorities

Minimum Qualification Requirements:

A degree or equivalent preferably in a scientific or health related field,

Two years clinical research experience or relevant experience preferred

Fluent German speaker and fluency in English is essential for this role.

Applied knowledge of project management processes and skills

Appreciation of / experience in compliance-driven environment

Ability to learn and comply with regulatory requirements and internal policies.

Effective communication, team work and problem solving skills

Very good attention to details and accuracy

Self-management and organizational skills

Excellent computer skills

Required language: German