Beschreibung
Are you an expert in Clinical Trial Document Management? Then you are the right person for this job!We are searching a CTA/ Clinical Trial Document Manager for our client in South Germany. You should bring along the following skills:
Education :
· University degree in life sciences
Languages:
· English and other major languages preferred
Experience:
· Minimum of two years of related experience in Biotech/Pharmaceutical/Medical Device and/or business administration industry preferred
· Demonstrated ability to work in a position demanding strong communication skills
· Must be well organized and adaptable
· History of working for multiple internal and external customers
· Experience with multiple software systems as well as other tracking / spreadsheet software systems
Project description:
1. Coordinates delivery and collection of trial documents to and from invesitgator sites/GCSMs; including facilitating IRB/IEC submissions.
2. Ensures accuracy and quality documents included in the site initiation packets.
3. Enters and maintains site information and document tracking in current clinical systems.
4. Ensures trial documentation is well organized, filed appropriately, and is available and current for the study team.
5. May specialize in preparation of SIP, budgets/contracts, or in other specialized functions as needed.
6. Follows applicable work processes, SOPs, communication plans, etc.
6. Ensures timely elevation of issues with sites related to preparation/collection of trial documents, initiation packets, site budget and contracts, etc.
7. Ensures timely elevation of issues with sites related to preparation/collection of trial documents, initiation packets, site budgets and contracts, or other relevant documentation.
8. Inspection readiness management.
9. May serve as a primary CTDM contact for small studies or for a specific document class (i.e. budget/contracts).
10. Works under only very general direction. Work may be reviewed for soundness of judgment and overall adequacy and accuracy.
Startdate: September 2014
Volume: full-time (freelance or temporary work)
Location: Bayern
Duration: 1 years with option for extensions
Are you interested in this Project? Please deliver your CV in Word-Format.
Kind regards,
Stefan Blöchl
Tags:
Pharmazie, Pharma, Medizin, Freelance, freiberuflich, befristet, Medical, Biologie, Onkologie, Orphan, drug, Master, Bachelor, GCP, GxP, Clinical, CRO, Studien, klinisch, TMF, Prüfplan, Prüfbogen, Monitor, CRA, CTA, Clinical Research Associate. Trial Master File.