Job Description

Entity:

CSL Behring

Job Category:

Research Development & Sciences

Job Family:

Clinical Development Operations

Job Type:

Full Time

Location

Remote, England, United Kingdom

Employer Reference:

R-269545

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Position Description and Summary

The Site Management and Monitoring Oversight is accountable for the strategic and operational oversight of investigational site management and monitoring activities across assigned clinical studies or programs. This role ensures that clinical trials are executed with high quality, regulatory compliance, and operational efficiency, in alignment with global clinical development strategies. Operating within a matrix environment, this role partners with internal stakeholders and external service providers to develop and implement study-specific oversight plans, monitor site performance, and proactively identify and mitigate risks. The role is pivotal in maintaining sponsor oversight, validating the effectiveness of study and site-level activities, and ensuring that monitoring plans and tools adequately address protocol-specific risks.

Main Responsibilities

Clinical Oversight & Compliance

Responsible for operational oversight of the site, site health and monitoring activities

Support QA audit and inspection planning, and implementation of CAPAs as needed

Identify and proactively mitigate site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs

Study Delivery Support

Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts

Support sites in understanding study expectations, timelines, and required deliverables

Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs

Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators/CROs

Site Relationship & Engagement

Build and maintain strong, trusted relationships with investigators and site staff - Face of CSL

Serve as the sponsor primary point of contacted for assigned studies

Understand site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaboration

Continuous Improvement & Site Experience

Collect feedback from sites and advocate for process simplification and burden reduction internally

Identify opportunities to improve study materials, and operational processes

Represent the "voice of the site" in cross-functional discussions and initiatives

Feasibility & Site Selection

Provide local site intelligence to feasibility teams

Support site development

Qualifications and Experience Requirements

Bachelor's degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology
12 years + relevant clinical research (or related) experience within the pharmaceutical industry
Experience in leading and managing a professional team along with site management, monitoring and overseeing large and/or complex global clinical trials
Extensive experience in drug development process and specifically, each step within the clinical trial process
Thorough knowledge of ICH guidelines/GCP for all stages in clinical development process
Experience in overseeing Vendors and CROs
Robust budget forecasting and management experience
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
Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report
Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges

About CSL Behring

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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/.

Our Benefits

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For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

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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 Employer

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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.