Lead Clinical Trial Master File Specialist
Debiopharm Group, Switzerland

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and bacterial infections in order to improving patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

Here: https://apply.workable.com/debiopharm-group-sa/

Debiopharm International S.A. identifies high-potential compounds for in-licensing, conducts clinical development and then selects large pharmaceutical commercialization partners to maximize patient access across the globe.

For our Clinical Operations organization based at our Headquarters in Lausanne, we are looking for a

Lead Clinical Trial Master File Specialist

In this role, you will lead and perform the activities related to the set-up, maintenance, close out and archiving of the electronic Trial Master File (eTMF) across all clinical development departments. You Ensure on-time filing and promote TMF inspection and Due Diligence readiness.

Your responsibilities will be but not limited to:

Administrative Activities

• Set up study eTMFs in Debiopharm’s Electronic Document Management Systems, including Veeva Vault eTMF (Veeva)
• Manage Veeva users’ accesses for CRO/Vendor staff and organise and provide Veeva trainings to CRO/Vendor staff
• In collaboration with the Clinical Trial Associate, enter and maintain milestones and EDLs in Veeva

Compliance

• Promote harmonization of document filing and eTMF management across departments; supervise the TMF champions initiative and setup of the TMF specialist organisation amp; management
• Analyse eTMF issue trends and escalated concerns, and supervise implementation of Corrective/Preventive Action
• Develop and improve work processes and systems to support document management, including contributing to SOPs and internal department guidance
• Coordinate cross-functional efforts in retrieval amp; management of TMF documents
• Own and maintain the Debiopharm TMF Plan Template and the Veeva guidelines
• Supervise the quality control of the documents filed in the eTMF
• Provide a current and accurate study eTMF status, and prepare eTMF metrics as needed for study team, top management or governance meetings
• Ensure quality of the documents filed in the eTMF and provide support during audits, due diligences and inspections.
• Work in accordance with Standard Operating Procedures (SOPs), Operative Instructions (OIs), GCP, ICH guidelines and study specific TMF Plans.

Documents Management

• Upload and approve documents in Veeva, perform eTMF Quality Control and liaise with study team and/or CRO to resolve identified issues
• Provide input on study-specific TMF Plans

Team Management

• Manage work allocation within the TMF Specialist team according to priorities and ensure fair distribution of workload
• Train and coach TMF specialists, as needed

Act as Veeva Vault eTMF Ambassador

• Ensure interface between IT and end-users and promote improvement of Debiopharm’s Veeva; review and test the central releases of Veeva Vault System for deployment in Debiopharm’s Veeva.
• Identify technical issues and collect suggestions for improvement from users
• Organise review and prioritisation with IT, collaborate on elaboration of the updates and participate in the UAT
• Review the training and communication material. Ultimately, train the CTA/CTM team
• Participate in the Clinical Study Database initiative and support the launch in specific studies
• Own the metrics reporting material.

Requirements

• University/College degree level or equivalent in a relevant discipline.
• Previous experience in the Pharmaceutical Industry or CRO with at least 1-2 years of administrative supporting experience in clinical research with good knowledge of TMF, GCP and drug development.
• Willingness to work with interdisciplinary teams, combined with curiosity about their tasks and operations.
• Advanced computer skills, mainly electronic system skills, including Microsoft Office applications and Adobe Acrobat. Previous experience in using an Electronic Document Management Systems (Veeva Vault is an adv

Job Rewards and Benefits