Document Management Specialist - Remote

Overview

As a Document Management Specialist you will be adding to the Clinical Operations team within Drug Development team at Owkin, ensuring the overall health of the Trial Master Files (TMFs) and supporting compliance with GxP.

In Short

• Responsible for high quality clinical document deliverables across global assigned studies.
• Key contributor and member of the clinical study team.
• Monitor completeness and quality of the Clinical TMF.
• Support monitoring of training record completion in the LMS.
• Ensure effective communication and issue escalation internally and with external vendors.
• Oversee consolidation, transmission and archive preparation of clinical TMF.
• Ensure compilation of CSR appendices in accordance with relevant processes.
• Champion inspection readiness through periodic quality assessment of clinical records.
• Support assigned TMF corrective action plans.
• Champion initiatives to enhance efficiencies in document management practices.

Requirements

• Robust pharmaceutical industry experience.
• In-depth experience of electronic document management systems (eTMF, eQMS, LMS).
• Solid knowledge of Data Privacy Regulations EU, UK & Global.
• Records management/TMF experience.
• Associates/Bachelor’s degree or equivalent preferred.
• Knowledge of regulatory requirements and ICH-GCP guidelines.
• Demonstrated ability to work independently and meet deadlines.
• Strong attention to detail and document organization skills.
• Solid communication skills and strong customer/stakeholder focus.
• Advanced computer proficiency, familiarity with Sharepoint.

Benefits

• Flexible work organization.
• Friendly and informal working environment.
• Opportunity to work with an international team with high technical and scientific backgrounds.