New · posted Nov 12
CSL · Biotechnology
Associate Director, Clinical Operations - Site Management & Oversight Lead (Americas)
- Remote, US
- Remote
- Full-time
- Director
The role
- 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
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.
What you need
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
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
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
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
Pay
CSL didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
From the posting
About CSL
About CSL Behring
CSL 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/.
You Belong at CSL
At 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, accessibility and legal noticesCSL's statements, word for word
Equal Opportunity Employer
CSL 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.
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
Director roles in the US43 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $201,000 | $233,000 | $244,000 |
Comparisons: the base pay employers published on open Clinical Operations roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Operations
The general path across 103 open Clinical Operations roles on Regulatory Jobs, with the titles they carry most. Not CSL's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 43 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct25
- Collaboration and leadership9
- GMP and compliance7
- Documentation and SOPs2
- Lab testing and methods1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Operations work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 15189(official source, opens in a new tab)Quality and competence of medical laboratories
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
Company hiring pulse
CSL on Regulatory Jobs
- 27
- Open roles
- 27
- Distinct roles
- 5
- Locations
By discipline
- Clinical14 52%
- Quality7 26%
- Regulatory6 22%
By level
- Director10 37%
- Senior & Principal10 37%
- Manager4 15%
More roles at CSL
- View role
Associate Director, Clinical Operations Site Engagement Lead
King of Prussia, PA +1 more · HybridDirectorBiotechnology$186K–$220K
- View role
Associate Director, Project Quality, Vendor Qualification
Kankakee, ILDirectorBiotechnology$172K–$203K
- View role
Director, Senior Global Regulatory Lead
King of Prussia, PA · HybridDirectorBiotechnology$242K–$270K
- View role
Global Principal Clinical Scientist - Cardiorenal
King of Prussia, PA +1 more · HybridSenior & PrincipalBiotechnologySalary not listed
Similar Clinical Operations roles elsewhere
- View role
Director, Clinical Operations
Relay TherapeuticsCambridge, MADirectorBiotechnologySalary not listed
- View role
Executive Director, Clinical Operations
Fate TherapeuticsSan Diego, CADirectorBiotechnology$280K–$300K
- View role
Associate Director, Clinical Operations (Contract)
4D Molecular TherapeuticsRemote, USDirectorBiotechnology$191K–$223K
- View role
Associate Director, Clinical Operations Study Lead
Dyne TherapeuticsWaltham, MADirectorBiotechnology$165K
Associate Director, Clinical Operations - Site Management & Oversight Lead (Americas) at CSL
Applications close November 18.