Clinical Document and Trial Master File (TMF) Manager

Noema is developing a late-stage portfolio of oral small molecule therapeutics with well-characterized mechanisms and distinct features that offer unique therapeutic advantages for neurological and other disorders. The Company is advancing three programs in parallel across orphan and large-market indications targeting therapeutic areas of high unmet need and limited competitioneach with blockbuster potential.

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 electronic (eTMF) 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 electronic global TMF system management by filing organizing and maintaining 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 all of Noemas programs.

• Expanding and leading the company documentation handling and filing processes across program and study functional areas (e.g. Clinical Clinical Development and Sciences Data Management Biostatistics etc.) 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 respective TMF Owner(s).
• 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 CROs 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
• Assist with the maintenance of legal document tracking tools e.g. CDAs MSAs workorders etc. and filing of final legal documents in the companys document management system
• Performing other activities for the study team and / or program team as assigned
• Adhere to and maintain training records to demonstrate an appropriate level of competence in compliance with GCP applicable regulations and SOPs.

Requirements

Candidates needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland. This is a hybrid position with 3 days working on-site in Basel.

Key Skills

B2C,Facilities Management,Ado,Bus Driving,Application Support,Arabic Cuisine

Employment Type : Employee

Experience : years

Vacancy : 1