TMF Specialist I (India)

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a TMF Specialist to join our A-team. The TMF Specialist I coordinates the indexing of documents within the Trial Master File at Allucent. This position controls and monitors the quality of documents filed in the TMF and completes the approval step for documents.

In this role your key tasks will include :

• Reviews documents for compliance with Good Document Practices and ALCOA+ standards.
• Reviews the categorization of documents to confirm that they are filed in accordance with the DIA reference model and Allucent TMF Index.
• Assess document metadata entered into the Veeva Vault system to verify that it reflects the study specific data entry instructions and is consistent with other documentation already present in the TMF.
• Where documents do not meet required standards – accurately assesses issues and returns the document to the document owner or indexer as required.
• Identifies trends in poor document completion and escalates these to the TMF Manager and TMF Lead as appropriate.
• Participates in team meetings to review practices and improve knowledge of TMF documentation.
• Mentors TMFS I.
• Actively support to staff learning & development within the company
• Draft and contribute as Subject Matter Expert (SME) in the field of Trial Master File Specialist activities to the evaluation / improvement of processes and procedures within the Quality Management System.
• Assure good communication and relationships with (future) clients
• Contribute and take part in client evaluations and visits

Requirements

To be successful you will possess :

Benefits

Benefits of working at Allucent include :

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.” #JC-1