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 TMF Specialist- Mechelen,BE
Core Purpose of Role:
TMF Subject Matter Expert and Single Point of Contact for the Clinical Study Leader, Clinical Study Team and other TMF stakeholders to ensure a complete and accurate TMF through documentation quality and consistency across clinical studies and programs. Provide crucial TMF quality support to and establish a proactive quality-focused partner-relationship with the Clinical Study Team.
- Act as subject matter expert and/or super user for GLPG eTMF tool; provide training to newcomers 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.
- Provide input on the revision of TMF related Work Instructions and SOPs
- Participate in the creation/harmonization of templates/guidances, e.g. document tracking tools, oversight tracking tools, training materials.
- Support Clinical Study Leaders (CSL) in the set-up of an eTMF for assigned studies:
- Set-up eTMF for each new study, prepare eTMF Table of Content/Study Specific Document List at study start and update as appropriate during study in agreement with CSL
- Maintain Study Specific Document Lists at the study, country and site levels by collaborating with all relevant stakeholders (e.g. Data Management, Clinical, Regulatory, etc.) to ensure placeholders are correctly and accurately in place for the study and all versions and instances are filed in a timely fashion.
- 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
- Create and maintain the study specific TMF Quality Plan (timing of document availability, delivery routes, scanning activities if required, timing and content of quality checks, any required paper originals to be filed, and responsibilities)
- Ascertain IT set-up of electronic gateway account for upload of external party ( CRO) eTMF upload
- Work with other departments to ensure CROs are informed/trained on agreed process for eTMF document transfer/delivery
- Support CSLs in the maintenance of study documentation including paper files for those originals still required to be filed, if applicable:
- Support multifunctional Clinical Study Team(s) and/or related stakeholders in resolving issues identified during electronic document uploads into internal systems (eTMF/DMS) and to ensure maintenance of TMF (both electronic and paper in state of Inspection Readiness
- Conduct detailed and appropriate Quality Checks on eTMF documents at defined time points, including any paper originals required
- 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
- Scan (or coordinate scanning by vendor), properly name, and import documents into eTMF to ensure availability as appropriate
- Maintain a global tracking of Trial Master File locations during study and upon archiving, e.g. GLPG TMF, ESP TMFs
- 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 – in cooperation with IT – smooth transfer of ESP TMF components into GLPG eTMF and proper archiving full eTMF
- Perform inventory activities for off-site storage records (old studies), as appropriate
- Participate in/present at departmental meetings
- Actively initiate and participate in Process Improvement initiatives
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
- Have at least intermediate Microsoft Office (Excel, PowerPoint, Word, Outlook, Excel) knowledge
- 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
- Be flexible, pro-active, self-motivated and able to work independently with minimal supervision. Be able to prioritize and seek input where necessary
- Good verbal and written communication skills
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…!