Entity: CSL Behring
Job Category: Research Development & Sciences
Job Family: Clinical Data Operations
Job Type: Full Time
Location: Barcelona, Catalunya, Spain
Employer Reference: R-269547
Job Description
Position Description and Summary
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.
This role plays a pivotal role in building and managing meaningful productive relationships with KOLs and key investigator sites
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 needes
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
This role will require travel to Investigator Meetings, Investigator sites and CROs. Anticipated travel >50%
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 science, nursing, pharmacy, medical laboratory technology
10 years + clinical research experience within the pharmaceutical industry
Experience in leading / managing a team as well as in site management, monitoring and overseeing large and/or complex global clinical trials
Must have a strong understanding and experience in drug development process and specifically each step within the clinical trial process
Must have strong budget forecasting and management experience
Extensive experience and knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
Experience / ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities
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.
About CSL Behring
CSL Behring is a integral 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
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
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 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.