Associate Director, Clinical Operations – Site Management & Oversight Lead

🔥 8 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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CSL

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1916

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $111M Post-IPO Equity on 2004-02

Healthcare • Biotechnology • Pharmaceuticals

CSL is a global leader in biotherapeutics and vaccines, focused on the needs of patients with serious and rare diseases. The company comprises CSL Behring, which develops and delivers treatments for conditions like immunodeficiency, hereditary bleeding disorders, and Alpha 1 Antitrypsin Deficiency; CSL Seqirus, a major provider of influenza vaccines; and CSL Vifor, which specializes in iron deficiency and nephrology. CSL operates an extensive R&D network focused on plasma fractionation, recombinant protein technology, cell and gene therapy, and vaccines. Headquartered in Melbourne, Australia, CSL serves patients in over 100 countries with a commitment to innovation and sustainable practices in biotechnology.

📋 Description

• Ensure effective conduct and supervision of site management activities and oversight for clinical programs across the assigned Americas region • Ensure sponsor oversight of conduct, monitoring, and management of clinical sites for one or more studies • Manage Clinical Site Ambassadors assigned to studies • Lead development or provide input into monitoring plans, audit plans, study management plans, and monitoring oversight plans • Coordinate regional CSA activities and serve as the primary contact for Site Management & Monitoring service providers across the region • Address, resolve, communicate, and escalate site-related issues • Maintain an overall view of site management and monitoring activities across clinical studies • Identify trends or systemic execution issues and ensure preventive or corrective actions • Build and maintain relationships with study sites, CSAs, service providers, and Medical Affairs stakeholders • Provide consolidated input into study feasibility across Americas countries • Contribute to CRO/vendor selection, budgets, and timelines • Oversee clinical program quality and compliance • Support patient recruitment objectives, site identification and selection, audit readiness, and inspection preparedness • Develop and refine oversight models and contribute to SMMOPs and CMPs • Oversee CRO recruitment strategy, RFPs, operational plans, and service-provider staff • Perform early and continuous site engagement and promote CSL’s pipeline in the Americas • Drive continuous improvement in site performance and monitoring practices • Identify and mitigate risks for clinical trial planning and execution • Collaborate with clinical development, regulatory affairs, and medical affairs stakeholders • Ensure regional execution aligns with global clinical strategy

🎯 Requirements

• Bachelor’s degree in the life sciences discipline, Nursing, Pharmacy, Medical Laboratory Technology, or other health/medical related area • 8+ years of relevant clinical operations experience within the pharmaceutical industry, including experience working in a global study team environment • 4+ years of clinical site monitoring experience, including 2+ years managing CRAs/monitors • Demonstrated solid understanding of the drug development and clinical trial process • Prior experience managing CROs • Demonstrated experience with issue management related to site monitoring • Previous experience with inspection readiness and audit follow-up audits • Thorough knowledge of ICH guidelines/GCP and applicability to all stages of clinical development • Experience training site monitoring CRO staff, study sites, and internal staff, and mentoring junior staff • Ability to work well within a matrixed environment • Effective interpersonal, written, verbal, and communication skills • Understanding of tasks involved in a clinical study from protocol development through final clinical study report • Ability to identify, solve, and escalate issues arising at study sites and within site management CROs • Extensive knowledge of ICH/GCP guidelines and current medical/scientific/regulatory knowledge • Demonstrated project management skills, including simultaneous management of multiple vendors, sites, and studies • Excellent planning, time management, and coordination skills • Ability to problem solve and use clear judgment regarding regulatory requirements, external-party interactions, timelines, and complex clinical studies

🏖️ Benefits

• Benefits information provided via CSL’s “How CSL Supports Your Well-being” resource • Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities