Job Details

Competitive Salary
Job Type
Roselle Cuntapay
11 months ago

A new entrant to Asia, this Biopharma is looking for an eTMF Manager in Singapore.
They have a number of trials taking place globally and are looking for an eTMF Manager to manage help with the trials on a global basis. This is a global role working with teams across the US, Europe and Singapore.
They offer a strong pipeline of oncology products to get stuck into, have already licensed their first product so are financially stable and will let you do things your way.

The eTMF Manager will be responsible for:

  • Provides oversight and sponsor-side maintenance of CRO-held electronic Trial Master Files to ensure Audit and Inspection readiness across all global clinical pipeline studies.
  • Collaborate with CROs to develop and finalize study-specific eTMF plans.
  • Review and ensure accuracy, compliance, and timeliness of eTMF documents.
  • Monitor and address eTMF trends, maintain Essential Document Lists, and support inspection-related activities.

The eTMF Manager will be/have:

  • Experience primarily working with eTMF. Veeva Vault preferred
  • Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management
  • Degree qualified

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