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Clinical Trials Specialist

1 week ago

Bengaluru, Karnataka, India Allucent Full time
Company Overview
We at Allucent are dedicated to facilitating the efficient navigation of clinical trials for small-medium biopharmaceutical companies, enabling them to bring life-changing therapies to patients worldwide. Our mission is to provide innovative solutions and exceptional support to our clients.

Job Description
The Trial Master File (TMF) Specialist I plays a pivotal role in ensuring the quality and compliance of documents within the TMF. This position involves coordinating the indexing of documents, controlling and monitoring their quality, and completing approval steps for documents. Key tasks include:
  • Reviewing documents for compliance with Good Document Practices and ALCOA standards.
  • Verifying the categorization of documents to ensure they are filed in accordance with the DIA reference model and Allucent's TMF Index.
  • Assessing document metadata entered into the Veeva Vault system to confirm its consistency with other documentation in the TMF.
  • Returning documents that do not meet required standards to the document owner or indexer as necessary.
  • Identifying trends in poor document completion and escalating them to the TMF Manager and TMF Lead as appropriate.
  • Participating in team meetings to review practices and improve knowledge of TMF documentation.

Required Skills and Qualifications
To be successful in this role, you will possess a life science, healthcare, or business degree and have a minimum of 2 years of relevant work experience processing documents within the TMF. You should also have good knowledge of GCP, GDPR, HIPAA, CRF, CTR, and applicable local regulatory requirements. Additionally, you should have strong written and verbal communication skills, including a good command of the English language, and be able to work effectively in a fast-paced environment.