TMF Specialist II

Overview

We are hiring for a TMF Specialist with 2 years of experience in the pharma/CRO space!! 

Responsibilities

Responsibilities

• Maintenance of electronic Trial Master File which may include the following:
• - Managing the controlled access process, including access training and monitoring
• - Managing study file structure process and documentation
• - Managing record archival and retrieval processes
• - Performing routine document quality control in the electronic file and conducting routine system tasks
• - Performing training cross-functionally to set expectations for filing in the Trial Master File
• Support internal and regulatory audits and inspections by making Trial Master File contents available as needed
• Lead TMF projects as assigned, such as (but not limited to):
• - Records retention, disaster/recovery
• - Quality reviews of TMF processes to identify issues and implement solutions
• - Performing Trial Master File oversight in the form of periodic risk-based QC reviews on documents
• - Participating in the development, implementation, and maintenance of electronic Trial Master File system
• Primarily works and collaborates with peers and Trial Master File users across departments
• Identifies trends and escalates to the Trial Master File System Owner
• May determine methods and procedures on new assignments.
• May participate in system administration and ad-hoc meetings to report on status, provide demonstrations of system functionality, and/or gather requirements for new or updated features
• Works under general supervision and on assignments that are moderately complex in nature where judgment is required in resolving routine problems and making routine recommendations.

• Adhere to CFR, GCP/ICH, ALCOAC CEA company policies, Clinical Development Operations, and project-specific quality documents (e.g., SOPs, work practices, training guides, defined Trial Master File key performance indicators)

Qualifications

Qualifications

• A minimum of 2 years clinical trial or Trial Master File experience preferred within the pharmaceutical or biotechnology industry
• Familiarity with the DIA Trial Master File Reference Model structure
• Basic knowledge and understanding of CFR and GCP/ICH
• Proficiency with Microsoft Office Products - Word, Excel, PowerPoint, SharePoint (preferred)
• Fundamental understanding of filing systems and organizational tools

Benefits of Working in ICON:Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.