P2248 - Trial Master File Operations Manager

Vor 2 Tagen

Lausanne, Schweiz Debiopharm Vollzeit

Description

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve 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. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first 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.

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.

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

Trial Master File Operations Manager

The TMF Operations Manager leads the activities related to the set-up, maintenance, close out and archiving of the electronic Trial Master File (eTMF) across all clinical development departments. S/He ensures on-time filing, risk-based quality control of TMF and promotes TMF inspection and Due Diligence readiness.

The TMF Operations Manager will oversee global TMF services provided by the TMF Operations team (TMF Specialists). S/he will be responsible for the oversight of processing, maintaining and archiving of all essential documents into the eTMF in compliance with the relevant Standard Operating Procedures, country regulations and industry best practice. S/He is responsible for ensuring standard service level agreements in relation to TMF management are maintained and supports the definition, implementation, execution and process improvement of TMF Management activities.

In addition, the TMF Operations Manager will have management of TMF Specialist/s, and have ownership of activity planning, resources, processes, systems, training, and performance management to ensure corporate and compliance needs are met. The TMF Operations Manager will guide the strategy and lead the delivery of TMF Operations’ objectives in ensuring the management of the essential documents.

**Your responsibilities will be but not limited to**:
Line Management of TMF Specialists

Setup of the TMF Operations group organization & management
Ensure appropriate resourcing of TMF Specialists across studies and manage work assignment
Monitor performance and quality of service delivery
Train and coach TMF Specialists
Write and coordinate review of TMFs Transfer Plan
Define and oversee TMF transfer activities of a program
Lead TMF audit or inspection preparation
Develop and/or review CAPAs when findings are detected during routine TMF audit
Identify trends and ensure lessons learned from TMF audits are shared and addressed to proactively prevent risks in future audits

Study support

Write and coordinate review of TMFs Transfer Plan
Define and oversee TMF transfer activities of a program
Lead TMF audit or inspection preparation
Develop and/or review CAPAs when findings are detected during routine TMF audit
Identify trends and ensure lessons learned from TMF audits are shared and addressed to proactively prevent risks in future audits

Process Improvement

Promote harmonization of document filing and eTMF management across departments; supervise the TMF champions group
Develop and improve work processes and systems to support TMF inspection /due diligence readiness including contributing or authoring of SOPs/WIs and internal department guidance
Ensure the Veeva training material for CRO/Vendor users is up-to-date
Own and maintain the Debiopharm TMF Plan Template
Own and maintain the overall Quality Control process of the eTMF; ensure users training and appropriate process execution
Analyze eTMF issue trends and escalate concerns, and supervise implementation of Corrective/Preventive Action
Provide support during audits, Due Diligences and inspections
Ensure TMF compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and study specific TMF Plans

Oversight of the Veeva Vault eTMF Ambassador activities

Ensure Veeva Vault eTMF meets user needs and contribute to feature release roadmap definition
Ensure system optimization across businesses
Support business process definition when a new feature is implemented and support prioritization of releases
May review the training and communication material.
**Requirements**:
Ensure Veeva Vault eTMF meets user needs and contribute to feature release roadmap definition
Ensure system optimization across businesses
Support business process definition when a new feature is implemented and support pr

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