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Director, regional head site mgmt & oversight, europe - (remote)

Esplugues de Llobregat
CSL Plasma
Director regional
Publicada el 21 enero
Descripción

Ph3Position Description and Summary /h3 pThe Director, Regional Head Site Management Oversight provides strategic leadership for clinical site operations, ensuring 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 timelines and budget. Acting as the strategic link between therapeutic areas and investigator sites, the role ensures high-quality execution of clinical programs. The Regional Head will lead both permanent and functional service-provider site management teams while cultivating strong strategic partnerships with service providers and CROs. The Regional Head will also develop strong and lasting relationships within Medical Affairs at the regional level and with HCPs. /p h3Main Responsibilities /h3 pClinical Oversight Compliance: /p ul liResponsible for operational oversight of the site, site health and monitoring activities /li liSupport QA audit and inspection planning, and implementation of CAPAs as needed /li liIdentify and proactively mitigate site‑level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs /li /ul pStudy Delivery Support: /p ul liProvide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts /li liSupport sites in understanding study expectations, timelines, and required deliverables /li liBe accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs /li liResponsible for enrollment support and ensure progress by responding to recruitment issues from investigators/CROs /li /ul pSite Relationship Engagement: /p ul liBuild and maintain strong, trusted relationships with investigators and site staff – Face of CSL /li liServe as the sponsor primary point of contacted for assigned studies /li liUnderstand site capabilities, constraints, and strategic priorities to improve site engagement and long‑term collaboration /li liThis role will require travel to Investigator Meetings, Investigator sites and CROs. Anticipated travel 50% /li /ul pContinuous Improvement Site Experience: /p ul liCollect feedback from sites and advocate for process simplification and burden reduction internally /li liIdentify opportunities to improve study materials, and operational processes /li liRepresent the “voice of the site” in cross‑functional discussions and initiatives /li /ul pFeasibility Site Selection: /p ul liProvide local site intelligence to feasibility teams /li liSupport site development /li /ul h3Qualifications and Experience Requirements /h3 ul liBachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology /li li12 years+ relevant clinical research experience within the pharmaceutical industry. /li liExperience in leading and managing a professional team with strong experience in site management, monitoring and overseeing large and/or complex global clinical trials /li liA solid understanding of the drug development process, and specifically, each step within the clinical trial process /li liRobust budget forecasting and management experience /li liThorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process /li liProven experience in overseeing vendors and CROs /li liMust have experience as a mentor and coach others through peer‑to‑peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities /li liSkilled at independently navigating new or novel indications, study/program approaches, and unique challenges /li liMust have excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report /li /ul h3About CSL Behring /h3 pCSL 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. /p pCSL 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. /p pTo learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at /p h3Our Benefits /h3 pFor more information on CSL benefits visit How CSL Supports Your Well‑being | CSL. /p h3You Belong at CSL /h3 pAt 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. /p pTo learn more about inclusion and belonging visit /p h3Equal Opportunity Employer /h3 pCSL 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 /p /p #J-18808-Ljbffr

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Inicio > Empleo > Empleo Gran Distribución > Empleo Director regional > Empleo Director regional en Esplugues de Llobregat > Director, Regional Head Site Mgmt & Oversight, Europe - (Remote)

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