eTMF CTA

at  Excelya

Excelya is currently seeking for a qualified candidate to join our team for the position of eTMF specialist.
The eTMF Clinical Trial Assistant (eTMF CTA) supports the project teams in the set-up and quality of eTMF of the clinical trials, according to the ICH-GCP guidelines and applicable Standard Operating Procedures (SOPs). The eTMF CTA reports to the eTMF Manager and works closely with the responsible for the project concerned Project Manager (PM) / Clinical Research Associate (CRA) / Clinical Trial Assistants (CTAs) / Study Start Up Specialists (SSUS) / all other roles involved in the update of the eTMF in order to meet all applicable KPIs and ensure the quality of the eTMF to the effective and timely accomplishment of all logistical and administrative issues relevant to clinical projects.

REQUIREMENTS:

• Holds a BA degree from Life Science University, technical institute and/or other relevant college graduate
• At least 1 year proven working experience in eTMF or similar positions
• Attention to detail
• Critical thinking
• Time management and strong organizational skills.
• Able to speak and write English fluently

EXPERIENCE:

Previous experience in a receptionist or administrative role (1-2 years preferred).
Proficiency in Microsoft Office (Word, Excel, Outlook) and other office software.

SUMMARY

• Type of job:Full-time
• Location:Hungary
• Capability:Clinical Research

MAIN RESPONSIBILITIES:

• Deeply acknowledge and strictly follow Excelya and sponsors’ SOPs, guidelines and appropriate local and international legislation.
• Responsible for the time quality review of all documents that are uploaded in the eTMF by the document owners.
• Issuing of quality issues in the system for the documents that cannot be approved within the timelines.
• Follow up on the replies and review of the open quality issues in order to ensure that they are resolved according to the timelines.
• Perform Inspection Readiness checks according to the timelines, issue Quality Issues and Follow up on their resolution.
• Support the eTMF Manager & Project Manager with audits and / or inspections.
• Ensure that the Key Performance Indicators relevant to the eTMF are met.
• Manage/create/contribute documentation related to a clinical study.
• Responsible to transforming pTMF to eTMF and transferring Excelya’s eTMF to Sponsor’s eTMF and vice versa.
• Supports eTMF Manager in communicating any recurrent issues that are identified in order for root cause analysis and action plan to be created.
• May undertake other tasks as they may be assigned from the supervisor that will concern Excelya.

COMPETENCIES FOR THE ROLE:

• Optimistic/ Positive mindset
• Excellent interpersonal and communication skills
• Fluency in English language, both written & verbal
• Previous working experience at a similar role