Transform the drug development process by joining our team as a Clinical Research Documentation Specialist. As a leading global contract research organization, we provide pharmaceutical, biotechnology, and medical device customers with clinical development, patient access, and technology solutions across 20+ therapeutic areas. Conducting operations in ~100 countries, we are revolutionizing drug and device development for partners and patients globally.
The Trial Master File (TMF) Team is integral to the success of clinical research by ensuring the organization, accessibility, and compliance of essential clinical trial documents. As a TMF Intern, you'll work closely with TMF operations and cross-functional teams to uphold the quality, accuracy, and audit readiness of trial documentation.
Key Responsibilities:
* Learn the Basics: Attend training sessions to understand the drug development process and how clinical trial documentation supports regulatory compliance.
* Document Management: Assist in document classification and organization within the TMF system to ensure documents are audit-ready and meet regulatory standards.
* Metrics Analysis: Analyze deliverable metrics to identify trends and areas for improvement in document management.
* Cross-functional Collaboration: Work with TMF operations and other teams to address documentation needs and challenges.
* Reporting Assistance: Contribute to reporting and tracking of TMF deliverables to support project timelines and quality standards.
Requirements:
* Bachelor's or master's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field.
* Strong attention to detail and analytical skills, with familiarity in MS Office, especially Excel.
* Proactive, enthusiastic, and eager to learn in a structured environment.
* Excellent communication and organizational skills to manage accuracy-focused tasks and collaborate effectively with cross-functional teams.