INACTIVE
Full-Time
Sr. Clinical Operations Manager
Posted on 3/22/2024
Develops RNAi-based therapies for diseases
Biotechnology
Compensation Overview
$170,000 - $200,000Annually
+ Competitive salaries + Excellent benefit package
Senior
Pasadena, CA, USA + 1 more
Required Skills
Communications
Management
Requirements
- Minimum 8 years in clinical research and development
- Preferred 3 years onsite monitoring/auditing/site management experience
- Preferred 3 years managing external clinical service providers on a clinical study
- Minimum 3 years in the role of managing a Phase 1-3 interventional trial
- Preferred 1 year managing direct reports
- Advance knowledge of ICH-GCP
- Excellent interpersonal, verbal and written communication skills
- Consistently display a high level of professionalism, diplomacy and respect for others
- Must be able to work collaboratively and professionally with team members and external service providers such as CROs
- Strong organizational skills and attention to detail
- Ability to multi-task and prioritize appropriately
- Proficient in clinical project management tools and techniques
- Ability to think critically and problem-solve effectively
- Accurate and timely in performance of duties
- Understands need for confidentiality in all aspects of position
- Proficient software skills (Outlook, Word, Excel, Power Point, MS Project)
- Proficient in Veeva eTMF and Medidata EDC
Responsibilities
- Serve as the main point of contact and coordination for assigned trials
- Accountable for the overall completeness and inspection readiness of the TMF for assigned studies
- Develop, manage, review and track study budgets and contracts
- Review and approve external service provider change orders, contract amendments, and invoices
- Provide accurate study drug utilization forecasts and periodic updates for assigned studies
- Review and approve study drug labeling and procurement of ancillary supplies
- Develop and approve Pharmacy Manual and associated study-specific templates and forms
- Support IRT system set-up, testing, and on-time activation
- Accountable for site and study-level IMP accountability and final reconciliation
- Oversee investigator identification, feasibility, selection and site activation
- Oversee management of investigative site issue escalations, performance and compliance issues
- Develop, review, approve and deliver site-level training and study level updates to investigative sites
- Oversee investigative site close-out activities
- Oversee execution of assigned studies, manage study timelines, operational plans, and CRO performance to achieve deliverables on time, on budget and with acceptable quality
- Oversee the development and finalization of clinical operational plans (eg Monitoring Plan, TMF Plan, Protocol Deviation Plan) case report forms, informed consent documents, study specific forms, study training and reference materials
- Contribute to the development of protocols, amendments, clinical study/periodic reports and investigator brochures
- Provide updates on study/site status as needed to management and to ensure timely updates are reflected on ClinicalTrials.gov and equivalent public trial registries
- Manage adherence to GCP and local regulations governing study execution
- Track, report and present study metrics, progress reports, and timelines
- Proactively identify and resolve trial-level risks and issues
- Assist in the external service provider selection
- Oversee external service provider (eg CRO, central lab, recruitment, homecare, etc.) set-up, activation, deliverables and close-out activities
- Support TA Management in program level projects or responsibilities as assigned
- Contribute to TA/Program-level documents and reports
- May serve as primary point of contact/TA representative to internal departments as assigned
- Provide guidance, mentorship and oversight to more junior Clinical Operations staff members
- Effectively collaborates and coordinates with external service providers and Arrowhead functional groups and departments such as Safety, Legal, Finance, Program Management, Medical Writing, Clinical Pharmacology, and Regulatory to achieve study deliverables
- Support the conduct and resolution of routine and focused study audits and inspections
- Participate in and represent Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of department when designated
- Maintain compliance with assigned procedures, guidelines, study plans and applicable regulatory requirements
- Develop, author, or own SOP/Work Instructions, forms or templates
Arrowhead Pharmaceuticals specializes in developing RNAi-based therapies using their TRiM platform, which leverages various RNA chemistries for tissue-specific targeting, enabling rapid and durable knockdown of disease-causing genes. The TRiM platform also utilizes ligand-mediated delivery, offering potential advantages such as simplified manufacturing, reduced costs, and improved safety.
Company Stage
IPO
Total Funding
$899.9M
Headquarters
Pasadena, California
Founded
2004
Growth & Insights
Headcount
6 month growth
↑ 8%1 year growth
↑ 27%2 year growth
↑ 61%INACTIVE