Senior Associate, Clinical Standards & Processes

Arrowhead Pharmaceuticals•San Diego, CA

5h•$105,000 - $130,000

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 Senior Associate, CS&P assists the Associate Director of Clinical Standards & Processes or designee with eTMF set-up and management, process improvement initiatives, and quality tasks across Clinical Operations activities.

Requirements

Bachelor’s Degree
At least 3 years of experience in Clinical Operations or similar function.
At least 2 years of technical experience working in eTMF system set-up and maintenance.
Thorough understanding of all applicable FDA ICH- GCP regulations and guidelines.
Thorough understanding of TMF standards and reference model.

Nice To Haves

Experience with Veeva Vault eTMF.
Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner.
Proficient in MS Office (Word, Excel, and PowerPoint).
Proficient in Smartsheets.
Ability to work in a team or independently.
Effective interpersonal, written and verbal communication skills.
Able to critically evaluate job tasks and the impact on overall study execution.
Strong problem-solving capabilities.
Effectively collaborates with Study Team members.
Exceptional organizational skills with the ability to multi-task and prioritize.
Attention to detail.
Ability to work with distributed team members and outside vendors

Responsibilities

Support study teams with eTMF set-up and maintenance.
Assist Senior Manager with eTMF and study TMF training for internal and external access.
Participate in eTMF user access process for CS&P in accordance to applicable SOP/WI.
Manage assignment and tracking of Veeva Vault study licenses.
Perform oversight to Third Party TMF Vendor and Veeva Vault eTMF System.
Provide sponsor oversight to eTMF quality metrics generated internally or from vendors.
Participate in review of SOPs and WIs during annual reviews or as needed.
Ensure Vendor Issues Tracker is kept up to date.
Manage Site Master List by overseeing site number assignment process.
Participate in health authority inspections preparation activities.
Assist with document preparation for any internal gap assessments or audits.
Prepare training refreshers for Clinical Operations staff on internal SOP/WI and other processes relevant to the department.
Assist with development of Clinical Operations documents (Forms, Templates, SOPs/WIs, Job Aids, Training Materials).
Initiate and/or participate in process improvement activities.