Associate Director, Clinical Operations – Site Management & Oversight Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Ensure the effective execution and supervision of site management activities and oversight for clinical programs within the designated Americas region.

• Guarantee sponsor oversight concerning the conduct, monitoring, and management of clinical sites for one or more studies.

• Oversee Clinical Site Ambassadors assigned to specific studies.

• Lead the development or contribute to monitoring plans, audit plans, study management plans, and monitoring oversight plans.

• Coordinate regional CSA activities and act as the primary liaison for Site Management & Monitoring service providers throughout the region.

• Address, resolve, communicate, and escalate any site-related issues.

• Maintain a comprehensive perspective on site management and monitoring activities across clinical studies.

• Identify trends or systemic issues in execution and ensure preventive or corrective measures are taken.

• Foster and sustain relationships with study sites, CSAs, service providers, and stakeholders within Medical Affairs.

• Provide consolidated input on study feasibility across countries in the Americas.

• Contribute to the selection of CROs/vendors, budget formulation, and timeline management.

• Supervise the quality and compliance of clinical programs.

• Assist in patient recruitment targets, site identification and selection, audit readiness, and inspection preparedness.

• Develop and enhance oversight models and contribute to SMMOPs and CMPs.

• Oversee CRO recruitment strategies, RFPs, operational plans, and service-provider staffing.

• Engage with sites early and continuously promote CSL’s pipeline in the Americas.

• Propel continuous improvement in site performance and monitoring practices.

• Identify and mitigate risks associated with clinical trial planning and execution.

• Collaborate with stakeholders in clinical development, regulatory affairs, and medical affairs.

• Ensure regional execution is in alignment with the global clinical strategy.

⛳️ Requirements

• Bachelor’s degree in a life sciences discipline, Nursing, Pharmacy, Medical Laboratory Technology, or another health/medical-related field.

• A minimum of 8 years of relevant clinical operations experience within the pharmaceutical industry, including experience in a global study team setting.

• At least 4 years of clinical site monitoring experience, with a minimum of 2 years managing CRAs/monitors.

• Proven solid understanding of the drug development and clinical trial processes.

• Prior experience in managing CROs.

• Demonstrated experience in issue management related to site monitoring.

• Previous experience with inspection readiness and follow-up audits.

• In-depth knowledge of ICH guidelines/GCP and their applicability to all phases of clinical development.

• Experience in training CRO staff on site monitoring, as well as study sites and internal personnel, while mentoring junior staff.

• Ability to thrive in a matrixed environment.

• Strong interpersonal, written, verbal, and communication abilities.

• Understanding of the tasks involved in a clinical study from protocol development through to the final clinical study report.

• Capability to identify, resolve, and escalate issues that arise at study sites and within site management CROs.

• Extensive knowledge of ICH/GCP guidelines and up-to-date medical/scientific/regulatory knowledge.

• Proven project management skills, including the simultaneous management of multiple vendors, sites, and studies.

• Exceptional planning, time management, and coordination abilities.

• Proficient in problem-solving and exercising sound judgment regarding regulatory requirements, external interactions, timelines, and complex clinical studies.

🏝️ Benefits

• Benefits information is available through CSL’s “How CSL Supports Your Well-being” resource.

• Equal Opportunity Employer.

• Reasonable accommodations available for applicants with disabilities.