Sr. Clinical Compliance Associate @ Arrowhead Pharmaceuticals

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 and San Diego, CA. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

The Sr. Clinical Compliance Associate assists the Director of Clinical Compliance with eTMF set-up and management, tracking of new hire training, and quality and compliance across Clinical Operations activities.

Responsibilities

Support study teams with eTMF set-up and maintenance
Manage assignment and tracking of Veeva Vault study
Prepare eTMF QC templates for quality eTMF reviews
Initiate quarterly eTMF reviews across programs
Set up and review flash reports on eTMF vendor metrics
Participate in review of SOPs and WIs during annual
Assist DCCT with new hire onboarding and training
Manage Vendor Issues Tracker with issues submitted from study team
Participate in health authority inspections preparation activities
Assist DCCT and QA with document preparation for any internal gap assessments or audits
Prepare training refreshers for Clinical Operations staff on internal SOP/WI
Assist ADCCT with development of Clinical Operations documents (forms, templates, SOPs/WIs)

Requirements:

At least 3 years of experience in Clinical Operations or similar function
At least 2 year of experience working in eTMF system set-up and maintenance (preferably experience with Veeva Vault eTMF)
Thorough understanding of all applicable FDA ICH- GCP regulations and guidelines
Experience with eTMF systems and TMF reference model
Ability to proactively perform and complete duties with minimal supervision in an accurate and timely manner
Proficient in MS Office (Word, Excel, and PowerPoint)
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

Preferred:

4 year college degree preferred

California pay range

$110,000—$140,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

All applicants must have authorization to work in the US for a company.

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