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 studies
- Key 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 plan
- Coordinates 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 sites
- Ensures all site-related issues are addressed, followed through to resolution and appropriately communicated on/escalated to the attention of the clinical study team
- Maintain 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 applicable
- Champions building and maintaining excellent working relationships with study sites, involving CSAs, the Site Management & Monitoring ESPs and Medical Affairs stakeholders
- Provides 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 studies
Work Environment:Up to 50% travel requirement within the Americas region (U.S., Canada, and LATAM)Key Responsibilities and Accountabilities:Strategic Leadership- Oversee the quality and compliance of clinical program execution
- Responsible for patient recruitment objectives across the clinical portfolio
- Support feasibility activities regarding site identification and selection
Clinical Oversight & Compliance- Develop and refine oversight model
- Contribute 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 targets
- Ensure adherence to ICH GCP and other applicable regulatory requirements
- Support audit readiness and inspection preparedness across regional sites
Vendor & CRO Management- Provide input on CRO recruitment strategy/site selection
- Review of RFP/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
Site Relationship & Engagement- Perform early and continuous site engagement activities and promote CSL's pipeline in the Americas region
- Drive continuous improvement in site performance and monitoring practices
- Identify and mitigate risks to ensure optimal clinical trial planning and execution
Cross-Functional Collaboration- Collaborate with internal stakeholders across clinical development, regulatory affairs and medical affairs
- Ensure alignment between regional execution and global clinical strategy
Minimum Qualifications:- 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 CRO
- 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 its applicability to all stages of the clinical development process
- Experience training site monitoring CRO staff, study sites and internal staff, as well as mentoring of junior staff
Competencies- Ability to work well within a matrixed environment
- Demonstrated effective interpersonal, written, verbal and communication skills
- Demonstrates innovation; possesses drive, energy and enthusiasm to deliver the program objectives
- Proven understanding of all tasks involved in a clinical study from developing a protocol through to finalizing a clinical study report
- Ability to identify, solve and escalate as necessary issues that arise at study sites and within site management CROs
- Extensive and comprehensive knowledge of ICH/GCP guidelines; maintains current medical/scientific/regulatory knowledge
- Demonstrated project management skills including simultaneous management of multiple vendors, sites and studies
- Possesses excellent planning, time management & coordination skills
- Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies
About 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.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our BenefitsFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSLAt CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity EmployerCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
