Clinical Trial Assistant

About us

Calliditas is a commercial-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. We have our headquarters in Stockholm, Sweden and offices in USA, Switzerland and France.

Calliditas’ lead product, TarpeyoTM, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments.

As of December 15th 2021, the FDA has approved the commercialization of Nefecon (TARPEYOTM) in the United States thus making it the first and only FDA-approved treatment. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com (http://www.calliditas.com/) for further information.

Position summary

Join us as our new Clinical Trial Assistant and become part of an exciting global environment. You will be a part of a group of colleagues having a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and different internal and external stakeholders.

In this role you will support the Clinical Operations Department and work closely with our Clinical Operation Leads in the day-to-day work of sponsor study planning, execution and reporting of clinical trials and clinical study oversight activities of Contract Research Organizations.

You will work with document management of processes of , e.g., study documents, TMFs, QC checks, monitoring. compliance, etc. In this role, you will truly be a part of the company’s journey in addressing niche indications with high unmet medical needs.

Key tasks and responsibilities

- Provide general administrative support and assistance to the internal project team, primarily the Clinical Operation Leads.

- Support the internal project team with ongoing conduct of studies including coordination of administrative tasks during the study process

- Contribute to applications & submissions by handling clinical-regulatory documents

- Assist in contact with clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements)

- Attend clinical project team meetings

- Set up, organize, and maintain clinical study documentation in the trial master file

- Quality control of and archival of the TMF after final study

- Contribute to development and improvements of processes within the clinical operational area, e.g., SOP writing and/or revisions, development of sponsor oversight tools, checklists, etc.

- Contribute to quality GCP compliance related activities and audit/inspection readiness

Education and experience requirements

We’re looking for you who have at least a completed high school degree and a minimum of five (5) years of experience of working with Clinical Research. Furthermore, you should have experience in computerized systems for information handling and documentation, good knowledge of Microsoft Office, excel for example, and be fluent in English and be comfortable both speaking and writing in English.

As a person, you must be thorough, flexible, and highly self-motivated. You can prioritize your work in an efficient manner and are not afraid of taking initiatives. To thrive in this role, we believe you enjoy a fast-paced working environment, where a lot is going on and where you need to juggle many things at once.

Reasons to join the Calliditas Team

- Be a part of a global leader in IgA- Nephropathy and a rapidly growing commercial-stage pharmaceutical company
- Be a part of the commercialization of TARPEYOTM and our focus to file for approval with EMA
- Be a part of developing medicines for rare liver diseases
- Get in on bonus and benefit programs
- Fast paced small company environment


Welcome to join the Calliditas Team!