Associate Director, Clinical Operations - Site Management & Oversight Lead (Americas)

CSL

About The Position

The Associate Director, Clinical Operations Site Management & Oversight Lead (SMOL) ensures effective conduct and supervision of site management activities and oversight for clinical programs in the assigned Americas region. The role aligns regional execution with overall strategy, international regulatory standards, and agreed quality, timeline, and budget objectives. The SMOL provides sponsor oversight of clinical site conduct, monitoring, and management for one or more studies and manages the Clinical Site Ambassadors (CSAs) assigned to those studies. As a key member of the clinical study team, the role leads or contributes to plans and documents governing site-level study quality and conduct. The SMOL coordinates regional CSA activities, represents the CSAs on studies, and serves as the primary regional point of contact for Site Management & Monitoring external service providers (ESPs). The role tracks site-related issues through resolution and escalates them appropriately; monitors site management and monitoring activities across studies to identify trends and systemic issues; and ensures corrective or preventive action. It also builds relationships with study sites and stakeholders, contributes regional feasibility input and CRO/vendor selection, and supports timely study delivery. The position includes travel of up to 50% within the Americas, including the U.S., Canada, and LATAM.

Requirements

Bachelor’s degree in life sciences, Nursing, Pharmacy, Medical Laboratory Technology, or another health or medical-related area.
At least 8 years of relevant clinical operations experience in the pharmaceutical industry, including experience working in a global study team environment.
At least 4 years of clinical site monitoring experience, including at least 2 years managing CRAs or monitors.
Solid understanding of drug development and the clinical trial process.
Prior experience managing a CRO.
Experience managing issues related to site monitoring.
Experience with inspection readiness and audit follow-up audits.
Thorough knowledge of ICH guidelines/GCP and their application throughout clinical development.
Experience training site-monitoring CRO staff, study sites, and internal staff, and mentoring junior staff.
Ability to work effectively in a matrixed environment.
Effective interpersonal, written, verbal, and communication skills.
Innovation, drive, energy, and enthusiasm in delivering program objectives.
Understanding of the tasks involved in a clinical study, from protocol development through finalization of the clinical study report.
Ability to identify, resolve, and escalate issues arising at study sites and within site management CROs.
Current medical, scientific, and regulatory knowledge, with comprehensive knowledge of ICH/GCP guidelines.
Project management skills, including simultaneous management of multiple vendors, sites, and studies.
Strong planning, time-management, and coordination skills.
Problem-solving ability and sound judgment concerning regulatory requirements, external interactions, timelines, and complex clinical studies.

Responsibilities

Oversee the quality and compliance of clinical program execution.
Be responsible for patient recruitment objectives across the clinical portfolio.
Support feasibility activities related to site identification and selection.
Develop and refine the site management and monitoring oversight model.
Contribute to the development of Site Management & Monitoring Oversight Plans (SMMOP) and Clinical Monitoring Plans (CMP).
Ensure monitoring and site management activities meet international regulatory standards, timelines, and budget targets, including adherence to ICH GCP and other applicable requirements.
Support audit readiness and inspection preparedness across regional sites.
Provide input on CRO recruitment strategy and site selection, and review RFPs and CRO operational plans.
Build and maintain strategic relationships with service providers and CROs.
Oversee permanent and functional service provider staff involved in site management activities.
Perform early and ongoing site engagement and promote CSL’s pipeline in the Americas region.
Drive continuous improvement in site performance and monitoring practices.
Identify and mitigate risks to support effective clinical trial planning and execution.
Collaborate with clinical development, regulatory affairs, and medical affairs stakeholders, ensuring regional execution aligns with global clinical strategy.
Ensure sponsor oversight of site conduct, monitoring, and management for assigned studies, and manage the assigned Clinical Site Ambassadors.
Coordinate regional CSA activities, represent CSAs on study teams, and serve as the regional point of contact for Site Management & Monitoring ESPs.
Track site-related issues through resolution and communicate or escalate them to the clinical study team as appropriate.
Monitor site management and monitoring activities across studies, identify trends or systemic issues, and ensure appropriate corrective or preventive actions.
Build and maintain effective working relationships with study sites, CSAs, service providers, and Medical Affairs stakeholders.
Provide consolidated Americas-region input into study feasibility, contribute to CRO selection and associated budgets and timelines, and support on-time study delivery.