Trial Master File (TMF) Specialist - 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) Specialist- Mechelen,BE
Core Purpose of Role:
You will be the Trial Master File (TMF) Subject Matter Expert and advisor for the Clinical Study Assistants (CSA), and other TMF stakeholders to ensure a complete and accurate TMF through documentation quality and provide crucial TMF quality support to the Clinical Study Team. You will establish a proactive quality-focused partner-relationship with the Clinical Study Team.
- Act as TMF subject matter expert;
- Support Clinical Study assistants (CSA) and Leaders (CSL) in the set-up and maintenance of an (electronic)TMF for assigned studies
- Support Clinical Study Teams and other relevant TMF stakeholders in understanding their TMF-related responsibilities, requirements and expectations; act as an ad-hoc member of the Study Team
- Conduct appropriate Quality Checks on GLPG TMF documents,
- Conduct Quality Review in vendor TMF systems
- Provide reports and metrics on completeness and quality of TMF documentation and content to CSL on regular basis; take the appropriate relevant actions to address gaps, issues and risks
- Maintain a study tracking of Trial Master File locations during study and upon archiving, e.g. GLPG TMF, vendor TMFs
- Support final QCs of GLPG and vendor TMF.
- Escalate any issues regarding TMF content, quality and follow-up to CSL and TMF Owner
- Ensure proper archiving of TMF components from all relevant stakeholders
- Support the Study Team in TMF document retrieval during Audits and Inspections (paper and electronic)
- Ensure smooth transfer of vendor TMF components into GLPG eTMF and proper archiving full eTMF
- Perform inventory activities for off-site storage records (old studies), as appropriate
Who are you?
- Graduate or Degree in administration, office management or scientific degree
- Minimum 3 years clinical research experience with relevant exposure to and 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
- Experience/knowledge of ICH/GCP E6(R2) guidelines on documentation requirements
- Ability to establish and maintain cooperative relationships, and work effectively with all levels of personnel on TMF management issues across multidisciplinary teams globally
- Ability to remain calm/focused in high-stress situations and maintain a high level of accuracy and attention to detail in fast-paced environment with shifting priorities
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…!