Clinical Document and Trial Master File (TMF) Specialist (80% - 100%)

Alentis Therapeutics, the Claudin-1 Company, is on a mission to treat cancer and reverse fibrosis. To this end, we are rapidly advancing a clinical pipeline of anti-Claudin-1 monoclonal antibodies. Our team is committed to unlocking the broad potential of our therapeutic target Claudin-1 and bringing much-needed medicines to patients suffering from solid tumors as well as kidney, liver, and lung fibrosis.

Tasks

Your tasks :

• Assist in the overall management, quality control and maintenance of essential clinical trials and other designated documents. including the maintenance of the sponsor TMF and CRO TMF oversight
• Support the company documentation handling and filing processes across functional areas (e.g., Clinical, Business Development, Laboratory, etc...). Assist in the handling, filing and tracking of final documents in the company documentation management system
• Support performing quality control (QC) review of documents to be filed in the sponsor eTMF system in accordance with standard operating procedures (SOPs), DIA TMF Reference Model and study specific TMF Plans
• Support in the conduct of periodic oversight QC of the CRO’s and Laboratories TMF
• Assist in activities related to audits / inspections related to the Trial Master File processes and activities and assisting with the development of corrective action plans related to Trial Master File findings
• Serving as TMF Subject Matter Expert to study teams and external partners
• Ensuring effective communication cross-functionally and issue escalation across TMF stakeholders
• Conducting all activities in compliance with Client and CRO SOPs and other regulatory guidance documents
• Adhere to and maintain training records to demonstrate an appropriate level of competence in compliance with GCP, applicable regulations and SOPs.
• Support the documentation and TMF Specialist in the day-to-day operational management and coordination of TMF activities (Quality control, archiving, indexing, etc.)
• Participate in study meetings and contribute to study status tracking, meeting minutes and documentation, clinical document review, laboratory sample tracking and managementWorking alongside other clinical operations professionals (e.g. CTMs / CTLs) supporting them in the operational execution of clinical trials (document and process implementation, study status and progress monitoring, compliance documentation, etc.)

Requirements

Benefits

We offer a competitive salary and opportunities for career growth and development. If you are a highly motivated and skilled scientist looking to join a dynamic and innovative team, please submit your CV.

Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. The working place is Allschwil, Switzerland with 2 days home office per week.

Alentis Therapeutics is a clinical-stage biopharmaceutical company developing breakthrough treatments for cancer and fibrotic diseases.