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

In this role you will be responsible for the overall management, quality and maintenance of essential clinical trial and other designated documents, including the set up and maintenance of the TMF, with a strong focus on ensuring that routine document management operations are performed with adherence with SOPs and ICH/GCP/TMF guidelines. This position plays a key role in both paper and electronic global TMF system management, by filing, organizing and maintaining paper and/or digital records and coordinating the document management activities performed by third parties, such as CROs, vendors, clinical sites, collaborators, as well as other internal and external team members to achieve inspection readiness in close collaboration with cross-functional teams for both Fibrosis and Oncology programs.

Your tasks:

• Expanding and leading the company documentation handling and filing processes across functional areas (e.g., Clinical, Legal, Finance). Handling, filing and tracking of final documents in the company documentation management system
• Leading the completion of the study specific sponsor TMF Plan and review of the CRO TMF plan and index in association with the TMF Owner
• Overseeing the set-up, maintenance, and archival of the study Trial Master File
• Performing quality control (QC) review of documents to be filed in the sponsor documentation system as well as in the CRO eTMF in accordance with standard operating procedures (SOPs), DIA TMF Reference Model and study specific TMF Plans
• Conducting periodic oversight QC of the CRO’s TMF to identify documentation gaps and quality issues and to initiate corrective actions
• Acting as the point of contact for 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
• Creation and maintenance of trial budget reconciliation tools. Filing and tracking of invoices from vendors/consultants including oversight of investigator payment process
• Creation and maintenance of legal document tracking tools e.g. CDAs, MSAs, workorders etc., and filing of final legal documents in the companies document management system
• May support the completion and maintenance of public registries in collaboration with Clinical or Business Development team leads
• Performing other activities as assigned
• Adhere to and maintain training records to demonstrate an appropriate level of competence in compliance with GCP, applicable regulations and SOPs.

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.