TMF (Trial Master File) 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 & Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), the UK (London), Germany (München), and in the US (Boston).
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 (Trial Master File) Specialist - Mechelen,BE
Scope of the job
As a TMF Subject Matter Expert (SME) you are responsible for a complete and accurate TMF with high documentation quality, ensuring continuous audit/inspection readiness. You provide crucial TMF quality support to the Clinical Study Team (CST) members and establish a proactive quality-focused partner-relationship with the CST-members.
You acts as SME and ensures accurate set-up, maintenance and archiving of the TMF. You initiate relevant plans and tools, keeps oversight on the content and supports quality reviews of the TMF, ensuring continuous audit/inspection readiness.
Set-Up and maintenance of TMF:
- Set-up and maintain the TMF for assigned studies:
- Set-up new studies in eTMF and in the pre-archive room
- Create, with input of the Clinical Study Team (CST) members, the study specific TMF plan and index worksheet; update the plans when needed throughout the study
- Maintain study specific Expected Document Lists (EDLs) at study and country levels by collaborating with all relevant stakeholders (e.g. Data Management, Clinical, Regulatory, etc)
- Ensure placeholders are correctly and accurately in place for the study
- Support CST-members in the management of study documentation (including uploading documents in eTMF, scanning, managing paper originals) ensuring a complete, contemporaneous, quality and audit/inspection ready TMF
- Support CST-members and other relevant TMF stakeholders in understanding their TMF-related responsibilities, requirements and expectations; act as an ad-hoc member of the CST
- Conduct appropriate Quality Reviews (incl. final quality review) on GLPG TMF documents
- Upon request, support CST members with Quality Review (incl. final quality review) of vendor TMF documents
- 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
- Support CST-members to ensure audit/inspection readiness of allocated stud(y)/(ies) at all time
- Escalate any issues regarding TMF content, quality and follow-up to CSL, TMF owner and flag major variances to functional line management; support the CST in TMF document retrieval during Audits and Inspections (paper and electronic)
- As applicable, interact with the Quality Management Lead and follow-up on audit reports
- Ensure a timely creation of a CAPA-plan and timely CAPA closure
- Ensure proper archiving of TMF components from all relevant stakeholders; ensure smooth transfer of vendor TMF components into GLPG eTMF and proper archiving of the full TMF
- Perform inventory activities and quality review if deemed necessary for on and off-site storage records of legacy studies, as appropriate
Internal primary point of contact for TMF related activities for assigned clinical stud(y)/(ies), working in close interaction with CST members
Who are you?
- Degree in administration, office management or science
- Minimum 2 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…!