Trial Master File (TMF) Operations Leader - Mechelen, BE
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Basel (Switzerland) and in Boston (US).
We are in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you.
We are looking for a Trial Master File (TMF) Operations Leader - Mechelen, BE
Scope of the job:
You will be the TMF Subject Matter Expert and advisor for the Clinical Study Teams on (e)TMF set-up, management, close-out and quality control to ensure a complete and accurate TMF. You will implement consistency across clinical studies and programs and provide crucial TMF quality support to and establish a proactive quality-focused partner-relationship with the Clinical Study Teams.
- Act as TMF subject matter expert and super user for GLPG eTMF tool; manage and maintain training for new comers and refresher training to existing users. Contribute to the development and assist with the implementation of the TMF specifications, such as process and system changes
- Communicate to the Clinical Study Assistants and TMF specialists on all aspects of the TMF projects.
- Provide input on the revision of TMF related Work Instructions, Guidelines, Forms (e.g. TMF plan, oversight/QC tracking tools) and SOP. Provide advice on the implementation of GLPG TMF procedures and standards
- Guide the study teams in the creation and maintenance of the study specific TMF plan
- Ensure – in cooperation with ITS – smooth transfer of vendor TMF components following Data import processes for electronic components.
- Set-up agreements with vendors (on governance level) on TMF processes and transfers
- Support multifunctional Clinical Study Team(s) and/or related stakeholders in resolving issues identified during TMF management, including during electronic document uploads into internal systems (eTMF/eDMS)
- Coordinate TMF related Inspection Readiness initiatives and provide input and advice to audit report responses
- Provide reports and metrics on completeness and quality of TMF documentation and content to Head Clinical Operations on regular basis; monitor timelines and document quality standards; take the appropriate relevant actions to address gaps, issues and risks; Analysis of error trends to promote continuous improvement, providing input to CSAs/ TMF specialist..
Who are you?
- Minimum Master in life sciences or equivalent by experience and good understanding of drug development as well as a solid experience in clinical study management is highly recommended.
- Experience in TMF management, knowledge of TMF Reference Model, ALCOA+ standard, Good Documentation Practices or relevant working experience in pharmaceutical/scientific environment: i.e. thorough understanding of the processes associated with the conduct of clinical studies and document management operations.
- Exposure to process improvement initiatives and creation of SOPs, guidelines and templates is highly recommended
- Experience working in a matrix managed environment and ability to adapt to corporate culture.
- Excellent knowledge of ICH/GCP E6(R2) guidelines and other applicable regulations.
- Ability to establish and maintain cooperative relationships, and work effectively with all levels of personnel on TMF management issues across multidisciplinary teams globally
What’s in it for you?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos : together we can make it happen…!