TMF Documentation and Archiving Manager


Reference Number: 895917-W
Type of placement: Contract, Contract
Location: Switzerland, North West


Focused on managing document filing and archive/ archiving retrieval of documentation, including but not limited to clinical development documents

Main Responsibilities:

  • Leading, guiding and directing the company’s archive with a GCP/GxP focus
  • Archiving and maintenance of existing paper and electronic documentation, including Trial Master Files
  • Evaluating, selecting, validating, implementing and managing the archiving system to ensure compliance with 21CFR part 11 and other applicable regulations
  • Inventory, classify, perform QC and completeness checks, set-up, maintain and archive pre-clinical and clinical study documentation (TMFs) in accordance with relevant regulations (all phases of study from concept to post approval)
  • Responsible for support and training related to archiving and best documentation practice to ensure documents are managed and archived in accordance with GxP regulations and guidelines and company SOPs
  • Inventorying documents and storing the information in a central database
  • Handling requests for archiving of documents internally and transfer of records from external vendors
  • Responsible for retrieval of documents internally and from external archive
  • Managing external archive service provider
  • Preserving records, documents, and objects, copying records to relevant formats as necessary
  • Creating, reviewing, maintaining and supervising company’s relevant procedures related to documentation and archiving including use of a DMS

Qualifications and Experience:

  • At least 3 years’ experience in records management / archiving in Pharma or Biotech environment. Records Management / Archiving degree is an asset
  • Experience with eTMF systems and Archiving systems
  • Sound knowledge and experience of GxP
  • Excellent software skills (i.e. MS Office tools)
  • Fluent in both written and spoken English
  • Relevant working/residency permit or Swiss/EU-Citizenship required