TMF Specialist II

1 month ago

Bengaluru, India Allucent Full time

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 The Trial Master File Specialist II (TMFS II) to join our A-team (hybrid*). TMF Specialist II 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.

*** Please note Looking for Candidates who can work hybrid from the Bangalore location ***

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:

  • To be Life science, healthcare and/or business degree.
  • Minimum 3 years of relevant work experience processing documents within the TMF.
  • Minimum 4 years of experience in drug development and/or clinical research.
  • Good knowledge of GCP, GDPR/HIPAA, CRF, CTR and applicable (local) regulatory requirements. 
  • Good knowledge of clinical trial documentation and DIA TMF reference model. 
  • Strong written and verbal communication skills including good command of English language.  
  • Representative, outgoing and client focused.  
  • Ability to work in a fast-paced challenging environment of a growing company. 
  • Administrative excellence.   
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint required. 
  • Good attention to detail. 

Benefits

Benefits of working at Allucent include:

  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Opportunity for remote/hybrid* working depending on location
  • Leadership and mentoring opportunities
  • Participation in our enriching Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“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.”

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