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Clinical Trial fluent German

Zoek Pin Durham, County Durham, England

£34600 - £43200/annum +5% bonus and great benefits

Permanent (Full time)

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

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

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