TMF Specialist II
1 week ago
At AllucentTM, we are committed to helping small-medium biopharmaceutical companies effectively navigate the complex world of clinical trials to deliver life-changing therapies to patients globally.
We are seeking a Trial Master File Specialist II (TMFS II) to join our exceptional team. The TMF Specialist II oversees the organization of documents within the Trial Master File at Allucent, ensuring quality and completing document approval steps.
Key responsibilities in this role:
- Reviewing documents for compliance with Good Document Practices and ALCOA+ standards.
- Validating document categorization against the DIA reference model and Allucent TMF Index.
- Checking document metadata in the Veeva Vault system to ensure accuracy and consistency.
- Addressing document issues and escalating trends in incomplete documentation.
- Participating in team meetings to enhance TMF practices and knowledge.
- Providing guidance to TMFS I.
- Supporting staff learning & development.
- Contributing as a Subject Matter Expert on TMF Specialist activities.
- Maintaining client relationships and participating in client evaluations.
Requirements:
- Degree in Life Sciences, Healthcare, or Business.
- Minimum 3 years of TMF document processing experience.
- Minimum 4 years of drug development/clinical research experience.
- Knowledge of GCP, GDPR/HIPAA, CRF, CTR, and regulatory requirements.
- Familiarity with clinical trial documentation and DIA TMF reference model.
- Strong written and verbal communication skills.
- Client-focused with administrative excellence.
- Ability to thrive in a fast-paced environment.
- Proficiency in Word, Excel, and PowerPoint.
- Attention to detail.
Benefits of working at Allucent:
- Comprehensive benefits package.
- Competitive salaries.
- Study/Training Budget for professional development.
- Flexible Working hours.
- Remote/hybrid work options.
- Leadership and mentoring opportunities.
- Participation in the Buddy Program.
- Internal growth and career progression.
- Employee referral program.
- Access to online training programs.
- Spot Bonus Award and Loyalty Award Programs.
Disclaimers:
*Our hybrid work policy allows employees 2 days in the office per week for those near our global offices.
"The Allucent Talent Acquisition team oversees recruitment for Allucent (US) LLC and affiliates. We do not accept unsolicited resumes from third-party recruiters or collaboration requests. Sending resumes to Allucent employees does not guarantee future employment. Candidates should not be submitted directly to our hiring managers or human resources."
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