Clinical Trails Assistant

hace 3 semanas

Buenos Aires, Argentina Novo Nordisk A tiempo completo

**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 English is preferable)
- Flair for IT systems & Experienced user of Microsoft Office Package (Outlook, Word, Excel, PowerPoint)

**About the Department**
We are one of the leading companies in the pharmaceutical industry in Argentina with more than 20 years in the country. The more than 170 people who are part of the affiliate, have a single and clear purpose: to improve the quality of life of patients.
In 2021 we were recognized as one of the three best companies to work for in Great Place to Work and in the first position among pharmaceutical companies.

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 55,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further.

**Contact**

**Deadline**

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds, and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in.
Together, we’re life changing.

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