Are you a detail-oriented and organised individual with a passion for clinical trials and regulatory compliance? Allucent is seeking a TMF Specialist to join our team and contribute to the success of our clients in the biopharmaceutical industry. As a TMF Specialist, you will play a critical role in ensuring the quality and compliance of documents filed in the Trial Master File (TMF).
🔍About the Role
As a TMF Specialist, you will be responsible for:
✅Document Review: Reviewing documents for compliance with Good Document Practices and ALCOA+ standards.
✅TMF Indexing: Reviewing the categorisation of documents to confirm that they are filed in accordance with the DIA reference model and Allucent TMF Index.
✅Metadata Verification: Assessing 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.
✅Quality Control: Identifying trends in poor document completion and escalating these to the TMF Manager and TMF Lead as appropriate.
🎓Requirements
✅Education: Life science, healthcare, and/or business degree.
✅Experience: Minimum 2 years of relevant work experience processing documents within the TMF and 2 years of experience in drug development and/or clinical research.
✅Skills:
Good knowledge of GCP, GDPR/HIPAA, CRF, CTR, and applicable regulatory requirements.
Strong written and verbal communication skills, including a good command of the English language.
Ability to work in a fast-paced, challenging environment.
Administrative excellence and proficiency with various computer applications.
💎What We Offer
✅Comprehensive Benefits Package: Competitive salaries and benefits package per location.
✅Professional Development: Departmental Study/Training Budget for furthering professional development.
✅Flexible Working Hours: Flexible working hours within reason.
✅Leadership and Mentoring Opportunities: Opportunities for leadership and mentoring.
✅Internal Growth Opportunities: Internal growth opportunities and career progression.
🚀 Apply Now!
Take the next step in your career 👇🏻
🔗 Apply Here
🧬About Allucent
Allucent is a leading provider of clinical trial services to the biopharmaceutical industry. Our mission is to help small to medium-sized biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.
🌍Conclusion
This TMF Specialist opportunity at Allucent is an excellent chance for individuals with a passion for clinical trials and regulatory compliance to join a dynamic team and contribute to the success of our clients. With a comprehensive benefits package and opportunities for professional development, Allucent provides a supportive work environment that fosters growth and development. Apply now and take the first step towards a rewarding career in clinical trials.