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• Research Technician/Assistant


• Research Technician/Assistant in Molecular Biology


• Clinical Operations Manager (based in Basel)


• QA Validation Specialist


• Clinical Document Specialist (based in Basel)


• Purification Development Technician/Assistant


• Clinical Database Developer


• Head of Purification & Drug Product Development

Clinical Document Specialist (basel in Basel)

CAREER OPPORTUNITY

Clinical Document Specialist (based in Basel)

Novimmune SA is a drug discovery and development company located in Plan-les-Ouates and Basel that focuses on developing antibody-based drugs for the treatment of inflammatory diseases, immune-related disorders, and cancer.  The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets.  The company has been purposefully targeting a number of orphan drug indications, with the express hope of eventually providing safe and effective treatment options to some of the often neglected populations suffering from rare diseases.

For the Basel office, Novimmune is currently seeking a Document Specialist to be responsible for the execution and maintenance of key documents in both our Clinical Science and Clinical Operations departments.

Description of main activities:

Trial Master File

• Support the Clinical Science and Clinical Operations teams in the maintenance of the Trial Master File (TMF) on rare disease studies


• Create, implement and maintain document tracker for each study


• Retrieving, renaming and filing documents in TMF (including backlog) in accordance with GCP and Novimmune’s SOPs & conventions


• Upkeep of the TMF Table of Contents  as instructed by the study team manager


• Document formatting support for Clinical Science documents


• Managing document-related communications with external vendors (translators, printing companies, archiving)


• Maintenance of the publication library, retrieval of publications necessary to support regulatory and scientific work


• Supports the collection of essential documents required from various Sites/CRAs


• Maintenance of the document tracker supporting Clinical Trials


• Maintenance of documents filed in the paper TMF


• Provide support in scanning documents for the TMF, including QC of documents


• Supports Quality Control of the TMF on a regular basis


• Indexing of files moved to archiving


• Document formatting support for Safety documents

General Support

• Support printing and assembly of documents from the TMF for distribution to sites ; including the Investigator Site File (as required)


• Provide regular support as needed


• Other activities as required

Skills and competencies:

• Previous experience in a document specialist position where organized file structures are imposed


• Experience with clinical trial processes and documentation, including Trial Master File and knowledge of ICH GCP would be a plus


• Ability to multi-task and stay focused on priorities, strong analytical skills


• Expertise with Microsoft suite


• Team spirit and strong service orientation


• Understanding of the Industry/Clinical trial process and drug development

If your profile matches the above description, please send us your CV, copies of your diplomas and motivation letter in English under the reference CD/ Doc Sp1 to the following email address: hr-recruitment@novimmune.com