CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
The Associate Director Site Management & Monitoring Oversight Lead is responsible for clinical operations strategic leadership to ensure conduct and oversight of monitoring and site management of clinical programs in the designated region following our strategy, appropriate international regulatory standards, and within the agreed timeframe and budget. This role will be the strategic interface between therapeutic areas and study management to ensure the quality of the delivery of the clinical program(s) at the site level. The Associate Director will oversee the permanent and functional service provider site management staff and build a strategic relationship with service providers and CROs at a regional level.
Main Responsibilities and Accountabilities
Strategic Leadership & Oversight
- Lead regional clinical operations strategy aligned with global clinical development goals.
- Ensure monitoring and site management activities meet international regulatory standards, timelines, and budget targets.
- Oversee the quality and consistency of clinical program execution at the site level.
Vendor & CRO Management
- Build and maintain strategic relationships with service providers and CROs.
- Oversee permanent and functional service provider staff involved in site management.
Operational Excellence
- Drive continuous improvement in site performance and monitoring practices.
- Identify and mitigate risks to ensure smooth clinical trial execution.
Cross-Functional Collaboration
- Collaborate with internal stakeholders across clinical development, regulatory, and data management.
- Ensure alignment between regional execution and global clinical strategy.
Compliance & Governance
- Ensure adherence to GCP, ICH, and applicable regulatory requirements.
- Support audit readiness and inspection preparedness across regional sites.
In addition
- Act as the primary point of contact both internally and externally (e.g., vendors) as applicable for anything study related.
- Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations.
- Support audits/inspections and resolutions of findings.
- Support in the development of new SOPs, guidelines etc and/ or participate in working groups about new processes.
- Functional leadership and mentorship of junior staff required; Act in advisory capacity to other clinops colleagues within and across TAs.
- When accountable to a set of studies and/or program (s) provides oversight and direction, ensuring appropriate delegation and delivery, inter-program efficiencies and applied learnings.
Job Qualifications and Experience Requirements
Education
At minimum, bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
Experience
- As a guide, a minimum of 10 years’ relevant clinical research (or related) experience within the pharmaceutical industry.
- Previous experience in leading and managing a team of professional staff.
- A solid understanding of the drug development process, and specifically, each step within the clinical trial process.
- Experience in site management and monitoring and overseeing large and/or complex global clinical trials.
- Robust budget forecasting and management experience.
- Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
Competencies
- Demonstrated ability to lead teams and work in a fast-paced team environment.
- Experienced in working within a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment
- Successfully demonstrated the ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities.
- Ability to evaluate, judge and make decisions regarding staff. Ability to teach/coaching and setting an example of ‘best practice’.
- Excellent interpersonal and decision-making skills.
- Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives.
- Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges.
- Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report.
- Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards.
- Extensive and comprehensive knowledge of ICH guidelines/ GCP, Maintains current medical/scientific/regulatory knowledge.
- Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
- Demonstrated ability to problem solve and use clear judgment in relation to interactions with external parties, timelines, and complex clinical programs.
- Excellent written and oral communication skills and maintains computer literacy in appropriate software.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at 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.
We want CSL to reflect the world around us
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. Learn more Inclusion and Belonging | CSL
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