The Position
The CTA provides assistance in all relevant aspects of trial preparation, execution and finalisation in order to facilitate the process towards timely clinical project deliverables of required quality; also is an essential member of the trial team and has a significant role in conducting trial related tasks in a proactive and independent manner.

Main responsibilities:
- Set-up/maintenance of Trial Master File (including eTMF) tasks according to NN SOPs (Country and Site-specific documents); Assist in/perform QC of trial documents (e.g. diaries, SI/ICF, etc.)
- Performs/verifies/coordinates with external vendors translation of trial related documents (from English to local language(s) and vice versa); Support in connection with submission to Ethics Committees at sites
- Manages relevant clinical IT systems, i.e. eTMF, databases created locally. Supports ordering and shipment of trial products and trial ancillaries supplies (e.g. local diaries, stationary, recruitment/retention materials)



to the sites; Informs the Local Depot involved in distribution of trial products for a specific clinical trial about all relevant requirements.
- Collect and retrieve site and country documents for completeness and accuracy from clinical team for systematic uploading them into eTMF in accordance with TOC for eTMF ensuring that the documents are compliant with Novo Nordisk SOPs and regulatory requirements
- Daily supports to NN CRAs, including handling of TMF/eTMF (Site Specific Documents); Set-up and maintenance of logs and tracking tools; Support CRA with iTMF reconciliation

Qualifications
- Student, bachelor or other degree, University/higher education (preferably life sciences)
- Administrative experience
- Preferably knowledge of medical/pharmaceutical terminology
- Good communication skills; Team oriented personality with high degree of flexibility; Quality mind-set with attention to details
- English verbal and written skills on intermediate level (fluency in Eng

📌 Clinical Trails Assistant (Buenos Aires)
🏢 Novo Nordisk
📍 Buenos Aires