Clinical Trials Document Manager

13 hours ago

Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €75,000 - €105,000
Job Overview

This role involves managing the creation, compilation and publishing of clinical trial reports to ensure timely submissions to health authorities. The successful candidate will have experience in document management systems and be able to work independently.

Responsibilities
  • Manage the creation, coordination and oversight of clinical trial reports for assigned studies.
  • Support the implementation of a submission document readiness strategy.
  • Execute vendor oversight plans, monitor service metrics and identify opportunities for improvement.
  • Develop and maintain processes for submission readiness, contribute to initiatives to improve business and technical aspects of submission readiness activities.
  • Collaborate with cross-functional stakeholders on the planning, preparation and delivery of high-quality documents within timelines.
  • Identify and communicate processing risks/trends/patterns related to clinical trial reports and work with key stakeholders to define and implement remediations.
Requirements
  • Bachelor's degree in life sciences/healthcare/pharmacy/information management and relevant industry experience.
  • English fluency (written, oral) required.
  • Thorough knowledge of clinical document management processes.
  • Advanced knowledge of clinical documentation practice guidelines & principles.
  • Experience of authoring, compilation and formatting of clinical trial reports according to ICH E3.
  • 3-5 years in clinical development/clinical operations or similar business area.
  • 2-3 years working experience with document management systems and excellent understanding of system structures and generic document management functionality.
  • Good understanding of technical processes and PC environment including Microsoft suite of products.
  • Advanced ability to work independently.
  • Experience with project work or project management in a global, cross-functional multicultural and international matrix organization.
  • Excellent communication, organization and tracking skills.

The company is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities served.

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