Job Title: Regulatory Affairs Manager Location: Maidenhead Contract: 12 Months / Hybrid 3 days per week onsite Hours: 37.5 hours per week Rates: 80-90p/h Job Description SRG are seeking a regulatory affairs manager for a leading pharmaceutical company based in Maidenhead. For this role you will be working in collaboration with line manager and/or Area Product Lead, is responsible for implementation of registration strategy to ensure the regulatory approval of commercially successful pharma products in the Europe region. Is responsible for ensuring effective product maintenance and lifecycle management, in line with legal/regulatory requirements and regional business needs. May also support European regulatory strategy for assets in development. Duties and Responsibilities In consultation with line manager and/or Area Product Lead; Provides clear and constructive Europe Region (Area) regulatory input and intelligence to Area and Global Regulatory & Development Project Teams via the Area and/or Global Regulatory Lead (GRL) in accordance with Area & Commercial objectives. Ensure planned drug development activities comply with Area guidelines and if they do not provide a critical analysis of the risks and issues with a remediation proposal. Support global product development strategy(s); outlining options for Scientific Advice/PIP/IMPD, coordinating preparation of briefing packages and co-ordinating and leading agency meeting preparation. Prepare strategy recommendations to global regulatory and development teams in order to shape the global product strategy in line with Area regulatory and commercial objectives Define & implement Area filing strategy (including CP, MRP, DCP); identifying risks and proposing mitigation. Lead, plan, conduct and implement regulatory activities in support of lifecycle maintenance in Area. Identify compliance risks and remediation activities proactively. GRPT & ARPT representative ensuring regulatory requirements/interests of Area & Affiliate are represented at GRPT Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance. Interface with EMA or Area Health Authority(s) for products within the Therapeutic Area on behalf of the Product Lead when required. Responsible for ensuring effective planning and tracking of activities, especially submissions and key correspondence. Ensures effective planning and tracking of activities via internal tools Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance. People Establishes strong and effective relationships with affiliates, area and global regulatory teams as well as cross-functional teams thereby ensuring RA activities are in line with regional business priorities. Potential to mentor less experienced Area regulatory colleagues as required Processes Follows Global Regulatory policies and procedures. Ensures that new processes are developed and implemented in order to leverage the global infrastructure and maximise efficiency, ensures that new processes are aligned with global policies, but also meet regional regulations and needs. Responsible for the Notification of Regulatory activities and RIM system entry/data accuracy for allocated projects. Responsible for ensuring forecasts are developed and actuals managed in line with regional requirements and communicating these to Area TA Head, GRL and R&D finance for assigned projects. Experience and Qualifications Graduate in Life Sciences in a relevant area. Sound knowledge of both pharmaceutical regulations and guidelines and national regulations within Area. Pharmaceutical industry experience in European Regulatory strategy development and regulatory procedures, EU centralised procedure essential. Experience of EU strategy for development assets e.g. scientific advice, paediatric investigation plans preferred. Experience working effectively across cultures and in complex matrixed environment. Excellent organizational skills and solution driven leadership style Essential Skills and Abilities Ability to prioritise and manage workload including managing multiple projects. Ability to work effectively and collaboratively across the organisation. Experienced in working effectively across cultures and in complex matrix environment. Good interpersonal and negotiation skills and the ability to influence others. Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
Oct 06, 2025
Seasonal
Job Title: Regulatory Affairs Manager Location: Maidenhead Contract: 12 Months / Hybrid 3 days per week onsite Hours: 37.5 hours per week Rates: 80-90p/h Job Description SRG are seeking a regulatory affairs manager for a leading pharmaceutical company based in Maidenhead. For this role you will be working in collaboration with line manager and/or Area Product Lead, is responsible for implementation of registration strategy to ensure the regulatory approval of commercially successful pharma products in the Europe region. Is responsible for ensuring effective product maintenance and lifecycle management, in line with legal/regulatory requirements and regional business needs. May also support European regulatory strategy for assets in development. Duties and Responsibilities In consultation with line manager and/or Area Product Lead; Provides clear and constructive Europe Region (Area) regulatory input and intelligence to Area and Global Regulatory & Development Project Teams via the Area and/or Global Regulatory Lead (GRL) in accordance with Area & Commercial objectives. Ensure planned drug development activities comply with Area guidelines and if they do not provide a critical analysis of the risks and issues with a remediation proposal. Support global product development strategy(s); outlining options for Scientific Advice/PIP/IMPD, coordinating preparation of briefing packages and co-ordinating and leading agency meeting preparation. Prepare strategy recommendations to global regulatory and development teams in order to shape the global product strategy in line with Area regulatory and commercial objectives Define & implement Area filing strategy (including CP, MRP, DCP); identifying risks and proposing mitigation. Lead, plan, conduct and implement regulatory activities in support of lifecycle maintenance in Area. Identify compliance risks and remediation activities proactively. GRPT & ARPT representative ensuring regulatory requirements/interests of Area & Affiliate are represented at GRPT Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance. Interface with EMA or Area Health Authority(s) for products within the Therapeutic Area on behalf of the Product Lead when required. Responsible for ensuring effective planning and tracking of activities, especially submissions and key correspondence. Ensures effective planning and tracking of activities via internal tools Supports co-ordination of the review of CMC, QRD, PSUR and labelling submissions and approval of product-related packaging as required to ensure regulatory compliance. People Establishes strong and effective relationships with affiliates, area and global regulatory teams as well as cross-functional teams thereby ensuring RA activities are in line with regional business priorities. Potential to mentor less experienced Area regulatory colleagues as required Processes Follows Global Regulatory policies and procedures. Ensures that new processes are developed and implemented in order to leverage the global infrastructure and maximise efficiency, ensures that new processes are aligned with global policies, but also meet regional regulations and needs. Responsible for the Notification of Regulatory activities and RIM system entry/data accuracy for allocated projects. Responsible for ensuring forecasts are developed and actuals managed in line with regional requirements and communicating these to Area TA Head, GRL and R&D finance for assigned projects. Experience and Qualifications Graduate in Life Sciences in a relevant area. Sound knowledge of both pharmaceutical regulations and guidelines and national regulations within Area. Pharmaceutical industry experience in European Regulatory strategy development and regulatory procedures, EU centralised procedure essential. Experience of EU strategy for development assets e.g. scientific advice, paediatric investigation plans preferred. Experience working effectively across cultures and in complex matrixed environment. Excellent organizational skills and solution driven leadership style Essential Skills and Abilities Ability to prioritise and manage workload including managing multiple projects. Ability to work effectively and collaboratively across the organisation. Experienced in working effectively across cultures and in complex matrix environment. Good interpersonal and negotiation skills and the ability to influence others. Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
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 Head of Site Management and Monitoring is a senior leadership role accountable for the strategic direction, operational execution, and quality oversight of global site monitoring activities across all phases of clinical development. This role is pivotal in ensuring that clinical trial execution meets regulatory, ethical, and scientific standards while enabling operational excellence in a highly outsourced environment. Roles & Responsibilities Strategic Oversight and Quality Governance: Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits, Compliance Oversight Programs, and site-level risk mitigation strategies. Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants, ensuring alignment with enterprise risk and quality objectives. Operational Excellence in Monitoring: Drive strategic oversight of site management and monitoring activities across all phases of clinical development. Ensure global execution is fully aligned with protocol-specific risk assessments, regulatory requirements, and development timelines. Ensure the CRO(s) maintain high-quality, inspection-ready operations while proactively identifying and resolving site-level issues in a dynamic environment. CRO and FSP Governance: Lead governance of and oversight of Clinical Research Organization (CRO) partnerships. Act as a key strategic partner and influencer with CRO leadership, building strong relationships to drive accountability, resolve quality and performance issues-often on a daily basis given the operational scale-and ensure delivery to protocol and regulatory expectations. Cross-Functional Leadership and Regulatory Readiness: Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure global site performance, inspection readiness, and continuous improvement. Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution, documentation, and alignment with regulatory standards and internal SOPs. Leadership and Capability Development: Lead a geographically dispersed team, fostering a culture of agility, accountability, and performance. Develop internal talent and oversee CRO capabilities to ensure consistent, high-quality oversight across a complex and evolving clinical operations landscape. Innovation and Risk-Based Monitoring Enablement: Champion the advancement of oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making. Drive innovation to meet the demands of large-scale, global clinical operations and deliver continual process optimization Qualifications & Experience Requirements Minimum undergraduate degree in life sciences or health/medical-related field; advanced degrees preferred. 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight. Proven leadership in managing global teams and implementing oversight strategies for site operations. Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight. Strong analytical, communication, and stakeholder engagement skills 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 Do work that matters at CSL Behring!
Oct 04, 2025
Full time
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 Head of Site Management and Monitoring is a senior leadership role accountable for the strategic direction, operational execution, and quality oversight of global site monitoring activities across all phases of clinical development. This role is pivotal in ensuring that clinical trial execution meets regulatory, ethical, and scientific standards while enabling operational excellence in a highly outsourced environment. Roles & Responsibilities Strategic Oversight and Quality Governance: Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits, Compliance Oversight Programs, and site-level risk mitigation strategies. Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants, ensuring alignment with enterprise risk and quality objectives. Operational Excellence in Monitoring: Drive strategic oversight of site management and monitoring activities across all phases of clinical development. Ensure global execution is fully aligned with protocol-specific risk assessments, regulatory requirements, and development timelines. Ensure the CRO(s) maintain high-quality, inspection-ready operations while proactively identifying and resolving site-level issues in a dynamic environment. CRO and FSP Governance: Lead governance of and oversight of Clinical Research Organization (CRO) partnerships. Act as a key strategic partner and influencer with CRO leadership, building strong relationships to drive accountability, resolve quality and performance issues-often on a daily basis given the operational scale-and ensure delivery to protocol and regulatory expectations. Cross-Functional Leadership and Regulatory Readiness: Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure global site performance, inspection readiness, and continuous improvement. Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution, documentation, and alignment with regulatory standards and internal SOPs. Leadership and Capability Development: Lead a geographically dispersed team, fostering a culture of agility, accountability, and performance. Develop internal talent and oversee CRO capabilities to ensure consistent, high-quality oversight across a complex and evolving clinical operations landscape. Innovation and Risk-Based Monitoring Enablement: Champion the advancement of oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making. Drive innovation to meet the demands of large-scale, global clinical operations and deliver continual process optimization Qualifications & Experience Requirements Minimum undergraduate degree in life sciences or health/medical-related field; advanced degrees preferred. 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight. Proven leadership in managing global teams and implementing oversight strategies for site operations. Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight. Strong analytical, communication, and stakeholder engagement skills 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 Do work that matters at CSL Behring!
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 Head of Site Management and Monitoring is a senior leadership role accountable for the strategic direction, operational execution, and quality oversight of global site monitoring activities across all phases of clinical development. This role is pivotal in ensuring that clinical trial execution meets regulatory, ethical, and scientific standards while enabling operational excellence in a highly outsourced environment. Roles & Responsibilities Strategic Oversight and Quality Governance: Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits, Compliance Oversight Programs, and site-level risk mitigation strategies. Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants, ensuring alignment with enterprise risk and quality objectives. Operational Excellence in Monitoring: Drive strategic oversight of site management and monitoring activities across all phases of clinical development. Ensure global execution is fully aligned with protocol-specific risk assessments, regulatory requirements, and development timelines. Ensure the CRO(s) maintain high-quality, inspection-ready operations while proactively identifying and resolving site-level issues in a dynamic environment. CRO and FSP Governance: Lead governance of and oversight of Clinical Research Organization (CRO) partnerships. Act as a key strategic partner and influencer with CRO leadership, building strong relationships to drive accountability, resolve quality and performance issues-often on a daily basis given the operational scale-and ensure delivery to protocol and regulatory expectations. Cross-Functional Leadership and Regulatory Readiness: Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure global site performance, inspection readiness, and continuous improvement. Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution, documentation, and alignment with regulatory standards and internal SOPs. Leadership and Capability Development: Lead a geographically dispersed team, fostering a culture of agility, accountability, and performance. Develop internal talent and oversee CRO capabilities to ensure consistent, high-quality oversight across a complex and evolving clinical operations landscape. Innovation and Risk-Based Monitoring Enablement: Champion the advancement of oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making. Drive innovation to meet the demands of large-scale, global clinical operations and deliver continual process optimization Qualifications & Experience Requirements Minimum undergraduate degree in life sciences or health/medical-related field; advanced degrees preferred. 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight. Proven leadership in managing global teams and implementing oversight strategies for site operations. Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight. Strong analytical, communication, and stakeholder engagement skills 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 Do work that matters at CSL Behring!
Oct 01, 2025
Full time
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 Head of Site Management and Monitoring is a senior leadership role accountable for the strategic direction, operational execution, and quality oversight of global site monitoring activities across all phases of clinical development. This role is pivotal in ensuring that clinical trial execution meets regulatory, ethical, and scientific standards while enabling operational excellence in a highly outsourced environment. Roles & Responsibilities Strategic Oversight and Quality Governance: Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits, Compliance Oversight Programs, and site-level risk mitigation strategies. Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants, ensuring alignment with enterprise risk and quality objectives. Operational Excellence in Monitoring: Drive strategic oversight of site management and monitoring activities across all phases of clinical development. Ensure global execution is fully aligned with protocol-specific risk assessments, regulatory requirements, and development timelines. Ensure the CRO(s) maintain high-quality, inspection-ready operations while proactively identifying and resolving site-level issues in a dynamic environment. CRO and FSP Governance: Lead governance of and oversight of Clinical Research Organization (CRO) partnerships. Act as a key strategic partner and influencer with CRO leadership, building strong relationships to drive accountability, resolve quality and performance issues-often on a daily basis given the operational scale-and ensure delivery to protocol and regulatory expectations. Cross-Functional Leadership and Regulatory Readiness: Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure global site performance, inspection readiness, and continuous improvement. Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution, documentation, and alignment with regulatory standards and internal SOPs. Leadership and Capability Development: Lead a geographically dispersed team, fostering a culture of agility, accountability, and performance. Develop internal talent and oversee CRO capabilities to ensure consistent, high-quality oversight across a complex and evolving clinical operations landscape. Innovation and Risk-Based Monitoring Enablement: Champion the advancement of oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making. Drive innovation to meet the demands of large-scale, global clinical operations and deliver continual process optimization Qualifications & Experience Requirements Minimum undergraduate degree in life sciences or health/medical-related field; advanced degrees preferred. 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight. Proven leadership in managing global teams and implementing oversight strategies for site operations. Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight. Strong analytical, communication, and stakeholder engagement skills 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 Do work that matters at CSL Behring!
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 Head of Site Management and Monitoring is a senior leadership role accountable for the strategic direction, operational execution, and quality oversight of global site monitoring activities across all phases of clinical development. This role is pivotal in ensuring that clinical trial execution meets regulatory, ethical, and scientific standards while enabling operational excellence in a highly outsourced environment. Roles & Responsibilities Strategic Oversight and Quality Governance: Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits, Compliance Oversight Programs, and site-level risk mitigation strategies. Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants, ensuring alignment with enterprise risk and quality objectives. Operational Excellence in Monitoring: Drive strategic oversight of site management and monitoring activities across all phases of clinical development. Ensure global execution is fully aligned with protocol-specific risk assessments, regulatory requirements, and development timelines. Ensure the CRO(s) maintain high-quality, inspection-ready operations while proactively identifying and resolving site-level issues in a dynamic environment. CRO and FSP Governance: Lead governance of and oversight of Clinical Research Organization (CRO) partnerships. Act as a key strategic partner and influencer with CRO leadership, building strong relationships to drive accountability, resolve quality and performance issues-often on a daily basis given the operational scale-and ensure delivery to protocol and regulatory expectations. Cross-Functional Leadership and Regulatory Readiness: Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure global site performance, inspection readiness, and continuous improvement. Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution, documentation, and alignment with regulatory standards and internal SOPs. Leadership and Capability Development: Lead a geographically dispersed team, fostering a culture of agility, accountability, and performance. Develop internal talent and oversee CRO capabilities to ensure consistent, high-quality oversight across a complex and evolving clinical operations landscape. Innovation and Risk-Based Monitoring Enablement: Champion the advancement of oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making. Drive innovation to meet the demands of large-scale, global clinical operations and deliver continual process optimization Qualifications & Experience Requirements Minimum undergraduate degree in life sciences or health/medical-related field; advanced degrees preferred. 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight. Proven leadership in managing global teams and implementing oversight strategies for site operations. Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight. Strong analytical, communication, and stakeholder engagement skills 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 Do work that matters at CSL Behring!
Oct 01, 2025
Full time
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 Head of Site Management and Monitoring is a senior leadership role accountable for the strategic direction, operational execution, and quality oversight of global site monitoring activities across all phases of clinical development. This role is pivotal in ensuring that clinical trial execution meets regulatory, ethical, and scientific standards while enabling operational excellence in a highly outsourced environment. Roles & Responsibilities Strategic Oversight and Quality Governance: Provide executive leadership in the development, execution, and continuous optimization of global oversight frameworks, including Monitoring Oversight Visits, Compliance Oversight Programs, and site-level risk mitigation strategies. Oversee GCP compliance and data integrity across a global footprint of more than 1,300 clinical trial sites and over 31,000 participants, ensuring alignment with enterprise risk and quality objectives. Operational Excellence in Monitoring: Drive strategic oversight of site management and monitoring activities across all phases of clinical development. Ensure global execution is fully aligned with protocol-specific risk assessments, regulatory requirements, and development timelines. Ensure the CRO(s) maintain high-quality, inspection-ready operations while proactively identifying and resolving site-level issues in a dynamic environment. CRO and FSP Governance: Lead governance of and oversight of Clinical Research Organization (CRO) partnerships. Act as a key strategic partner and influencer with CRO leadership, building strong relationships to drive accountability, resolve quality and performance issues-often on a daily basis given the operational scale-and ensure delivery to protocol and regulatory expectations. Cross-Functional Leadership and Regulatory Readiness: Partner with Clinical Operations, Quality Assurance, Regulatory Affairs, and CRO stakeholders to ensure global site performance, inspection readiness, and continuous improvement. Serve as the escalation lead for site-level quality and compliance issues, ensuring timely resolution, documentation, and alignment with regulatory standards and internal SOPs. Leadership and Capability Development: Lead a geographically dispersed team, fostering a culture of agility, accountability, and performance. Develop internal talent and oversee CRO capabilities to ensure consistent, high-quality oversight across a complex and evolving clinical operations landscape. Innovation and Risk-Based Monitoring Enablement: Champion the advancement of oversight technologies, dashboards, and analytics to support proactive, risk-based monitoring and data-driven decision-making. Drive innovation to meet the demands of large-scale, global clinical operations and deliver continual process optimization Qualifications & Experience Requirements Minimum undergraduate degree in life sciences or health/medical-related field; advanced degrees preferred. 12+ years of experience in clinical operations, with a strong background in site monitoring and vendor oversight. Proven leadership in managing global teams and implementing oversight strategies for site operations. Deep understanding of ICH-GCP, regulatory frameworks, and best practices in sponsor oversight. Strong analytical, communication, and stakeholder engagement skills 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 Do work that matters at CSL Behring!
