Manager, TMF Operations

Arrowhead Pharmaceuticals; San Diego (CA); Vor Ort; USD 125.000 - 145.000; Vollzeit

Zusammenfassung

Arrowhead Pharmaceuticals, Inc. is seeking a Manager of TMF Operations to lead and oversee eTMF processes, ensuring SOP/WI alignment and GDP compliance across studies. The role focuses on optimizing TMF workflows and coordinating with outsourced vendors and CROs.

The onsite position in San Diego requires 5 days a week in the office, with responsibilities spanning staff training, metrics tracking, and collaboration with Quality Assurance to prepare for health authority inspections and audits.

Qualifikationen

• 5+ years in clinical operations, clinical quality, or quality assurance.
• 2+ years in a managerial or lead role.
• Fundamental knowledge of US, EU and international regulatory standards (ICH GCP, FDA, EMA).
• Experience in inspection.
• Strong knowledge of vendor management and eTMF systems.

Aufgaben

• Oversee eTMF processes and ensure compliance with SOPs/WIs and GDP.
• Provide leadership on study-related eTMF issues and vendor interactions.
• Ensure metrics and tracking systems for proactive quality management.
• Manage eTMF system administration and user access.
• Collaborate with QA on inspections, audits, and CAPAs.
• Support process improvements across Clinical Operations.

Kenntnisse

TMF management

Clinical operations

Vendor management

Regulatory knowledge

GCP knowledge

Team leadership

Ausbildung

Bachelor’s degree in a Science discipline

Tools

Smartsheet

Jobbeschreibung

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial 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 Manager of TMF Operations will act as the internal TMF lead on studies, ensuring oversight to outsourced TMF work (vendor and/or CRO) and performing oversight to TMF metrics and trends. In addition, the Manager of TMF Operations may be tasked with projects that ensure proper framework of TMF related processes and ongoing compliance to Standard Operating Procedure/ Work Instruction (SOP/WI) and Good Clinical Practice (GCP)/Good Documentation Practice (GDP). The primary purpose of the position is to oversee the eTMF processes and vendors, ensure compliance with GCP and consistency across the programs, and to provide guidance and best practices to Clinical Operations.

This role is onsite 5 days a week in San Diego.

Responsibilities

• Ensure staff are provided GCP/SOP/WI training for Clinical Operations staff and refreshers where applicable.
• Provide leadership, guidance and oversight on study related issues pertaining to the eTMF, and company processes.
• Ensure the collection of metrics and tracking systems to facilitate a proactive, risk-based quality management
• Assist Associate Director with eTMF system administration functions (TMF Operations is the business owner of the eTMF system).
• Manage eTMF and Study TMF training for internal and external user access.
• Oversee TMF Operations role in eTMF user access process in accordance with applicable SOP/WI and elevate issues as required to Senior Management
• Direct junior TMF Operations staff with eTMF set-up, maintenance, ongoing quality control review, and final reconciliation of study
• Oversee clinical vendor management and elevate issues as required to Senior
• Collaborate with Quality Assurance on health authority inspection preparation activities and provide leadership and oversight during
• Collaborate with Quality Assurance with the preparation, conduct and response to internal and external audits/inspections, as applicable.
• Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to COM and Senior Management, as
• Contribute to the development of Clinical Operations documents (forms, templates, SOPs/Wls).
• Ensure consistency and standardization of processes across Clinical Operations.
• Collaborate with other cross functional areas (Safety, Regulatory, Legal, Finance, Project Management and QA) to ensure operational
• Support the Associate Director of TMF Operations and Clinical Operation Senior Management in leading various process improvement initiatives.
• May manage direct reports.

Requirements

• 5+ years of relevant experience in clinical operations, clinical quality, or quality assurance role
• 2+ years in a managerial or lead role
• Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations)
• Experience in inspection
• Strong knowledge/experience in vendor management, clinical operations and management of electronic Trial Master Files (eTMFs).

Preferred

• 2+ years in TMF experience
• Bachelor’s degree in a Science discipline
• Knowledge of industry compliance trends
• Proficient in Smartsheets

California pay range

$125,000—$145,000 USD

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.

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