TMF Specialist / Document Management Specialist (m|f|d)
Job Description
In this role, you will be responsible for collecting, reviewing, maintaining, and archiving essential regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, and Clinical Trials Regulation, and our Standard Operating Procedures (SOPs).
- You are responsible for the TMF health, including oversight and management of document submissions, indexing and filing (both paper & electronic), QC / QR
- Management of periodic and / or sponsor QC reviews of the TMF to ensure completeness, timeliness, and quality of the TMF and works directly with the document owners to identify issues, performs completeness checks, and uploads documents to the eTMF and / or paper TMF as applicable
- Furthermore you develop metrics and reports and you have the oversight of the CRO study-specific trial master files
- Training and mentoring activities for new and current staff to foster TMF awareness.
Qualifications
- You possess a completed science degree in life sciences, healthcare, or Medical Documentation (Med. Dokumentation) or an equivalent field.
- A minimum of several years of demonstrable experience in professional Trial Master File (TMF) management is essential, comprehensive knowledge of the DIA reference model is required.
- Proficiency in TMF management is crucial as well as extensive experience in document uploading, reviewing, quality control (QC), and approval of study-required documents is mandatory.
- Strong attention to detail and ability to maintain the highest standards of document management are imperative and excellent organisational skills and the capacity to manage multiple priorities effectively are essential.
- Proficient communication skills in both written and verbal English are required.
Additional Information
What we offer
- A modern workplace in Bergisch Gladbach with opportunity for some mobile work. Exciting opportunities in the development of technologies with a secure future.
- Cross-border intercultural cooperation and short communication channels
- A collegial corporate culture and flexible working hours enable time management on your own terms
- Personalized employee development program : specialist and personal training courses provided by our own Miltenyi University
- Diverse corporate benefits with regard to employee health, sport, and staff events
We look forward to your application
If you want to work in an open, creative and supportive team, this is the place for you. We look forward to receiving your application along with your salary expectations and availability.
Senior-Specialist International Steering & Management Invoice Control (m/w/d)
Slogan, sondern eine Einstellung.Wir lieben Technik und wir wollen begeistern.Wir haben Spaß und wir wollen inspirieren.Deshalb suchen wir Menschen, die diesen Spirit mit uns teilen.Die sich darauf freuen, gemeinsam mit 50.Mitarbeitenden in ganz Europa das Einkaufserlebnis der Zukunft zu gestalten.D...
TMF Specialist / Document Management Specialist (m|f|d)
Management of periodic and/or sponsor QC reviews of the TMF to ensure completeness, timeliness, and quality of the TMF and works directly with the document owners to identify issues, performs completeness checks, and uploads documents to the eTMF and/or paper TMF as applicable. Proficiency in T...
International Revenue Management Specialist in Salzburg
FMCG/consumer goods experience, ideally in Revenue Management, Key Account Management, Category Management, or Insights. Join Our Team and Shape the Future of Revenue Growth Management Globally!. Your expertise will contribute to our success story and shape the future of revenue growth management gl...
Material Management Specialist (m/w/d)
Unser Kunde ist europäischer Marktführer in der Lebensmittelbranche.Unser Spezialist im Bereich der Herstellung von zahlreichen Produkten hat sich in Deutschland und weltweit durch permanente Anpassung trendgerechter Produktkonzepte etabliert.Du bist verantwortlich für alle Werke am Standort Bergisc...
Specialist Unified Endpoint Management L2 & L3 (m/w/d)
Du verantwortest den technischen Remote-L2/L3-Support (Backend) im Bereich Client Management für Win 10/11, Thin + Fat Clients (Win + Apple), hauptsächlich Intune, JAMF, SCCM, für verschiedene Kunden im deutschen Bankensektor. ...
Personalsachbearbeiter Lohn und Gehalt / Payroll Specialist (m/w/d)
Sie haben eine abgeschlossene kaufmännische und/oder steuerrechtliche Ausbildung oder oder ein vergleichbares Studium, idealerweise mit dem Schwerpunkt Personalmanagement oder Arbeitsrecht. Sie sind sicher im Umgang mit MS Office und haben idealerweise auch bereits Erfahrung mit Personalmanagement-S...
Specialist Projects Portfolio & Performance Management (w/m/d)
Specialist Projects Portfolio & Performance Management (w/m/d). Als Specialist Projects Portfolio & Performance Management (w/m/d) bist Du verantwortlich für die ITS-CLMS-Konfiguration. ...
Student Service Specialist (m/w/d)
Student Service Specialist (m/w/d). Student Service Specialist (m/w/d). Die International School of Management (ISM) ist eine staatlich anerkannte Hochschule und zählt zu den führenden privaten Hochschulen in Deutschland. Student Service Specialist (m/w/d). ...
Knowledge Management Expert / Specialist (w/m/d)
Zielgerichtetes Wissensmanagement. Als wichtige Schnittstelle zum Kerngeschäft arbeitest du im Bereich Knowledge Management eng mit unseren Beratern zusammen. Dank unseres breiten Kundenportfolios im In- und Ausland erhältst du vielfältige Einblicke in Einkaufs- und Supply Chain Management Themen un...
Document Specialist Technical Documentation (m/w/d)
In Ihrer neuen Aufgaben als Document Specialist Technical Documentation (m/w/d) unterstützen Sie maßgeblich die Betriebe bei der Pflege der technischen As-Built Anlagedokumentation. Ihre Erfahrungen bringen Sie in der Data- and Document-Management Community ein und tragen so zu einer Harmonisierung ...