Trial Master File Operation Manager (Temporary 24 months)

Job content

Description

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/

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

Trial Master File Operation Manager (Temporary 24 months)

Our TMF Activities are growing and we are hiring for additional and temporary support to 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. In this role, you would also be expected to train and mentor our TMF Specialist.

Your responsibilities will be but not limited to:
Processes

Promote harmonization of document filing and eTMF management across departments; supervise the TMF champions initiative and setup of the TMF specialist organisation & management
Develop and improve work processes and systems to support document management, including contributing to SOPs and internal department guidance
Lead the implementation of EDLs in Veeva across the company to support TMF completeness
Maintain the Veeva training material for CRO/Vendor users up to date
Own and maintain the Debiopharm TMF Plan Template and the Veeva guidelines
Own and maintain the Quality Control process of the eTMF; ensure users training and appropriate process execution
Analyse eTMF issue trends and escalated concerns, and supervise implementation of Corrective/Preventive Action
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
In specific circumstances, may 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

Act as Line Manager of the TMF Specialists (2-3 people)
Manage work allocation within the TMF Specialists team according to priorities and ensure fair distribution of workload
Train and coach TMF specialists, as needed

Oversight of the Veeva Vault eTMF Ambassador activities

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

Study documents management

Requirements
University/College degree level or equivalent in a relevant discipline.
Previous experience in the Pharmaceutical Industry or CRO with at least 4-5 years of clinical documents management experience (process and execution level) 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 advantage)
Extensive knowledge and application of the TMF Reference Model, ALCOA-C standard, Good Clinical Practice (ICH GCP E6 (R2), FDA 21 CFR Part 11), Good Documentation Practices and any other relevant are preferred
Confirmed experience in people management highly preferrable or previous involvement in team members’ coaching
Experience in TMF transfer is an advantage
Fluency in English required (C1), French is an advantage
You have a strong team spirit and service orientation with exceptional organizational skills
You are known for your dynamism, pro-activity and attention to details

Benefits
An international and highly dynamic environment, with a long-term vision.
The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry and be exposed to many areas within clinical development and the pharmaceutical industry.
The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.

The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.

Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.

Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.