Clinical Doent and Trial Master File TMF Specialist

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

Tasks

• Expanding and leading the company doentation handling and filing processes across functional areas (e.g., Clinical, Legal, Finance). Handling, filing and tracking of final doents in the company doentation management system
• Leading the completion of the study specific sponsor TMF Plan and review of the CRO TMF plan and index in ociation with the TMF Owner
• Overseeing the set-up, maintenance, and archival of the study Trial Master File
• Performing quality control (QC) review of doents to be filed in the sponsor doentation 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 doentation 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 isting 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 doents
• 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 doent tracking tools e.g. CDAs, MSAs, workorders etc., and filing of final legal doents in the companies doent management system
• May support the completion and maintenance of public registries in collaboration with Clinical or Business Development team leads
• Performing other activities as igned
• 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 doent management best practices is mandatory
• Broad understanding of records management requirements in Drug Development
• Experience performing Quality Control of TMF doents 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 et
• Pro-active attitude, acting with sense-of-urgency and applying an entrepreneurial mindset
• Ability to think ytically, identify problems as they are occurring (proactive management), and rapidly identify and implement solutions that are GCP compliant
• Excellent organizational and planning ss, including strong attention to detail
• Strong interpersonal ss. Ability to collaborate effectively with the study team, cross-functional team members and external partners (CROs, vendors)
• Excellent communication ss. Proficiency in English (written and oral)
• Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland