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

Associate Director, Clinical Operations Site Management & Oversight Lead (SMOL)The purpose of the Associate Director, Clinical Operations Site Management & Oversight Lead (SMOL) is to ensure the effective conduct and supervision of site management activities and oversight for clinical programs within the assigned region. This includes alignment with our overall strategy, adherence to international regulatory standards, and delivery within agreed quality, timelines and budget.Position Overview:Ensure adequate sponsor oversight of the conduct, monitoring and management of clinical sites for one or more clinical studies, across the Americas region, and manage the Clinical Site Ambassadors (CSAs) assigned to the studiesKey member of the clinical study team and leads the development or provides input into the plans and documents that govern the quality management and conduct of the clinical study at study sites, such as the monitoring plan, audit plan, study management plan, monitoring oversight planCoordinates the activities of the CSAs in the region for the assigned studies, represents all CSAs on the study, and is the primary point of contact for Site Management & Monitoring ESPs across the region to ensure high quality conduct and execution of clinical studies at clinical study sitesEnsures all site-related issues are addressed, followed through to resolution and appropriately communicated on/escalated to the attention of the clinical study teamMaintain overall view of the site management and monitoring activities across the clinical studies; identifies trends or systemic issues in the study execution on site, site management and monitoring, and ensures preventive or corrective actions are taken, involving stakeholders as applicableChampions building and maintaining excellent working relationships with study sites, involving CSAs, the Site Management & Monitoring ESPs and Medical Affairs stakeholdersProvides consolidated input into study feasibility from countries across the Americas region; contributes to the vendor selection of Site Management & Monitoring CRO and associated budget and timelines; and supports the on-time delivery of clinical studiesWork Environment:Up to 50% travel requirement within the Americas region (U.S., Canada, and LATAM)Key Responsibilities and Accountabilities:Strategic LeadershipOversee the quality and compliance of clinical program executionResponsible for patient recruitment objectives across the clinical portfolioSupport feasibility activities regarding site identification and selectionClinical Oversight & ComplianceDevelop and refine oversight modelContribute to the development of the Site Management & Monitoring Oversight Plans (SMMOP) and the Clinical Monitoring Plans (CMP)Ensure monitoring and site management activities meet international regulatory standards, timelines, and budget targetsEnsure adherence to ICH GCP and other applicable regulatory requirementsSupport audit readiness and inspection preparedness across regional sitesVendor & CRO ManagementProvide input on CRO recruitment strategy/site selectionReview of RFP/CRO operational plansBuild and maintain strategic relationships with service providers and CROsOversee permanent and functional service provider staff involved in site management activitiesSite Relationship & EngagementPerform early and continuous site engagement activities and promote CSL's pipeline in the Americas regionDrive continuous improvement in site performance and monitoring practicesIdentify and mitigate risks to ensure optimal clinical trial planning and executionCross-Functional CollaborationCollaborate with internal stakeholders across clinical development, regulatory affairs and medical affairsEnsure alignment between regional execution and global clinical strategyMinimum Qualifications:Bachelor's degree in the life sciences discipline, Nursing, Pharmacy, Medical Laboratory Technology, or other health/medical related area8+ years of relevant clinical operations experience within the pharmaceutical industry, including experience working in a global study team environment4+ years of clinical site monitoring experience including 2+ years managing CRAs/monitorsDemonstrated solid understanding of the drug development and clinical trial processPrior experience managing CRODemonstrated experience with issue management related to site monitoringPrevious experience with inspection readiness and audit follow-up auditsThorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development processExperience training site monitoring CRO staff, study sites and internal staff, as well as mentoring of junior staffCompetenciesAbility to work well within a matrixed environmentDemonstrated effective interpersonal, written, verbal and communication skillsDemonstrates innovation; possesses drive, energy and enthusiasm to deliver the program objectivesProven understanding of all tasks involved in a clinical study from developing a protocol through to finalizing a clinical study reportAbility to identify, solve and escalate as necessary issues that arise at study sites and within site management CROsExtensive and comprehensive knowledge of ICH/GCP guidelines; maintains current medical/scientific/regulatory knowledgeDemonstrated project management skills including simultaneous management of multiple vendors, sites and studiesPossesses excellent planning, time management & coordination skillsDemonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studiesAbout CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. Seqirus