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

• Bachelor’s Degree required in science/health-related field
• 5+ years’ working experience in the biotech and pharma industry
• A minimum of 3 years’ experience with electronic Trial Master Files (eTMF) solutions (Veeva Vault Clinical, PhlexTMF other eTMF platforms) is a must
• Solid experience with the DIA TMF Reference Model, ALCOA+ standard and document management best practices is mandatory
• Broad understanding of records management requirements in Drug Development
• Experience performing Quality Control of TMF documents and CRO oversight QCs
• Experience supporting audits and regulatory inspections
• Familiarity with various aspects of clinical trials and regulatory requirements for clinical trials (ICH/GCP, FDA, EU-CTR).
• Basic understanding of the clinical trial budget and reconciliation process is an asset
• Pro-active attitude, acting with sense-of-urgency and applying an entrepreneurial mindset
• Ability to think analytically, identify problems as they are occurring (proactive management), and rapidly identify and implement solutions that are GCP compliant
• Excellent organizational and planning skills, including strong attention to detail
• Strong interpersonal skills. Ability to collaborate effectively with the study team, cross-functional team members and external partners (CROs, vendors)
• Excellent communication skills. Proficiency in English (written and oral)
• Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland

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.