Intern – Clinical Operations

Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.

The Opportunity

Denali is seeking a motivated candidate for an internship position in the Clinical Operations team to support the management and oversight of its Trial Master Files in accordance with Good Clinical Practice standards.

Responsibilities

• Assist with filing and reconciliation of clinical trial documentation
• Track, maintain, and perform quality check of study documents
• Support clinical study teams with ongoing oversight of the Trial Master File (TMF) by ensuring documents meet GxP standards
• Communicate with cross-functional study team members and external partners to ensure appropriate management of the TMF
• Identify gaps and escalate quality issues to the clinical operations study lead
• Participate in the development of TMF tools and processes, including SOPs, work instructions, templates and other applicable reference materials

Requirements

• Candidates pursuing a BS degree in a scientific discipline
• Self- and results-driven, organized, resourceful, adaptable and collaborative
• Bold and creative thinker with a curious nature, eager to learn about the complexities of the business of healthcare and biotech
• Evident communication and analytical skills
• High degree of proficiency with the MS Office Suite or Google equivalent
• Strong organizational skills, critical thinking and ability to juggle multiple projects
• Experience with Good Documentation Practice (GCP), records management and/or the TMF Reference Model is preferred