Beschreibung
Aktuell unterstützen wir ein renommiertes, forschendes Pharmaunternehmen mit Sitz in Hessen auf der Suche nach einem TMF / ETMF QC Specialist.Responsibilities:
- Trial Master File maintenance and filing of relevant documents according to ICH-GCP and SOPs (as required), respective archiving and electronic filing of documents.
- Perform QC of documents submitted to the eTMF
- Address questions pertaining to how documents are filed in the eTMF for users
- Assist with capturing the identified TMF metrics for the eTMF
- Perform ad hoc archiving tasks
- Assistance with the preparation/collection of all study documents (e.g. protocol, CRF, forms, manuals, contracts, etc.) and presentation materials.
- Track various program-related activities/documents such as project team calendars, monitoring frequency and others. Periodically distribute tracking documents to predetermined contacts.
Requirements:
- sound experience in the field of Clinical Oprations as CTA and/or CRA
- very experienced in working with TMF and eTMF
- Demonstrated ability to work in a position demanding strong communication skills
- Must be well organized and adaptable
- Experience with multiple software systems as well as other tracking / spreadsheet software systems
- English (very good), German (good)
Details:
Startdatum: Februar 2017
Dauer: 6+ Monate
Volumen: 1,0 FTE
Ort: on site / remote (50/50), Hessen, Germany
Art der Anstellung: Arbeitnehmerüberlassung oder Freelance
Wenn Sie Interesse an dieser Position haben, freue ich mich auf Ihre Rückmeldung. Ich melde mich dann so schnell wie möglich bei Ihnen zurück.
Für mehr Informationen über Progressive Recruitment besuchen Sie www.progressiverecruitment.com/de.