Summer Intern, Clinical Operations (Training & Systems)

Arrowhead Pharmaceuticals•San Diego, CA

21d•Onsite

About The Position

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Clinical Operations eTMF Training & Systems Intern will support the Clinical Standards and Processes (CSP) group at Arrowhead Pharmaceuticals by developing training materials and resources for the electronic Trial Master File (eTMF) system. This internship offers hands-on experience creating user-focused training content while supporting process improvement and inspection readiness efforts within Clinical Operations. The intern’s work will help ensure consistent, accurate use of the eTMF system by internal and external study team members. This is an 11-week Summer Internship Program paying $24.00 per hour and requires full-time, onsite work five days per week at the designated location.

Requirements

Currently enrolled student at an accredited university or college (junior or senior preferred).
Experience with Smartsheet, Clipchamp, or SharePoint.
Relevant coursework in clinical research, life sciences, or health sciences.
Strong problem-solving and organizational skills.
Proficiency in Microsoft Office applications.
Interest in clinical operations, documentation standards, or quality systems.

Nice To Haves

Familiarity with TMF or eTMF systems (e.g., Veeva)

Responsibilities

Create and produce training videos for eTMF system functionality, including:
Submitting records via email ingestion and batch upload
Completing Quality Issues (QI)
Indexing records and routing for QC
Performing initial QC
Updating lifecycle states
Record, edit, and upload finalized training videos to the Training Vault or reference materials within the eTMF system.
Develop job aids, templates, and quick reference guides to supplement SOPs, work instructions, and training videos.
Partner with CSP and applicable functional teams to update and format study plan templates for formal release in Veeva QualityDoc.
Support Smartsheet tracker projects for CSP, based on team bandwidth and priorities.
Assist with TMF oversight activities for older studies prior to archival, as needed.
Collaborate with Clinical Operations stakeholders to support inspection readiness and TMF quality initiatives