TMF Specialist I

You will be joining Allucent, a company dedicated to aiding small-medium biopharmaceutical companies in efficiently navigating the complex world of clinical trials to bring life-changing therapies to patients worldwide. As a TMF Specialist at Allucent, your main responsibility will involve coordinating the indexing of documents within the Trial Master File. You will be in charge of ensuring the quality of documents filed in the TMF and completing the approval step for documents. Key Responsibilities: - Review documents to ensure compliance with Good Document Practices and ALCOA+ standards. - Confirm the categorization of documents according to the DIA reference model and Allucent TMF Index. - Verify document metadata in the Veeva Vault system aligns with study-specific data entry instructions and existing documentation in the TMF. - Accurately assess issues with documents that do not meet standards and return them to the document owner or indexer. - Identify trends in poor document completion and escalate to the TMF Manager and TMF Lead when necessary. - Participate in team meetings to enhance knowledge of TMF documentation and practices. - Mentor TMFS I and actively support staff learning & development. - Contribute as a Subject Matter Expert in Trial Master File Specialist activities for process and procedure evaluation/improvement within the Quality Management System. - Maintain good communication and relationships with current and potential clients. - Participate in client evaluations and visits. Qualifications Required: - Life science, healthcare, and/or business degree. - Minimum 2 years of relevant work experience processing documents within the TMF. - Minimum 2 years of experience in drug development and/or clinical research. - Good knowledge of GCP, GDPR/HIPAA, CRF, CTR, and applicable regulatory requirements. - Familiarity with clinical trial documentation and DIA TMF reference model. - Strong written and verbal communication skills in English. - Client-focused, outgoing, and representative demeanor. - Ability to excel in a fast-paced, challenging environment. - Proficiency in Microsoft Word, Excel, and PowerPoint. - Attention to detail. About Allucent: Allucent offers a range of benefits such as comprehensive benefits package, competitive salaries, study/training budget, flexible working hours, remote/hybrid working options, leadership and mentoring opportunities, internal growth and career progression, employee referral and loyalty award programs, access to online training platforms, and participation in the enriching Buddy Program. Please note that Allucent's hybrid work policy entails 2 days in the office per week for employees within reasonable distance from one of the global offices.,