London-Based International Corporate Bank: looking to make a vital hire as Head of Internal Audit, small team Head of Internal Audit - International Corporate Bank Main Responsibilities & Accountabilities:Leadership & Strategy- Review the existing audit methodology to develop and execute a risk-based internal audit strategy;- Prepare and regularly update the annual Audit Plan for submission to London Branch Audit Committee and the Head Office Internal Audit Bureau (IAB) for approval.- Lead, mentor and manage the Internal Audit team, fostering a high-performance culture;- Act as the primary liaison with the Board Audit Committee, presenting audit findings and insights.- Ensure that the External Quality Assessment (EQA) is implemented effectively. Audit & Assurance- Provide independent assurance on the adequacy and effectiveness of internal controls, governance, and risk management;- Oversee the delivery of audit engagements across all business areas, with emphasis on key areas including treasury, lending, operations, IT and Compliance;- Ensure audit work is performed in accordance with professional standards;- Undertake special investigations at the request of the Audit Committee and/or the CEO;- Evaluate the effectiveness of remediation actions and track issue resolution;- Maintain, regularly review and refine relevant audit related policies and procedures (e.g. Audit Manual, Internal Audit Findings Risk Appetite Policy, London Branch Audit Committee Terms of Reference, Auditor Independence Policy);- Maintain an up-to-date "audit universe" for the Bank as the business develops;- Including high level review of bank-wide operational policy and procedure manuals as part of the audit work undertaken;- Consider opportunities to enhance co-operation and interaction with fellow group entities wherever possible;- Complete mandatory training as required, and undertake other necessary training to ensure an appropriate level of technical knowledge is maintained;- Oversee the effective deployment of the Internal Audit Management System to maximise benefits; Risk Management & Compliance- Assess emerging risks and adjust audit plans accordingly;- Maintain strong awareness of UK regulatory expectations (e.g. PRA, FCA requirements);- Co-ordinate with Compliance, Risk and external auditors to ensure effective coverage and minimal duplication;- Support regulatory reviews and inspections, as required. Stakeholder Management- Build strong relationships with Senior Management and business heads;- Maintain a good relationship with IAB and ensure that IAB requests are managed on an effective and timely basis;- Provide constructive challenge and actionable recommendations to improve business processes;- Communicate complex risk and control issues clearly to both technical and non-technical stakeholders;- Act as secretary to the London Branch Audit Committee, and facilitate the effective and efficient workings of the London Branch Audit Committee;- Work with the Chairman of the Audit Committee to ensure that relevant regulatory regulations are complied with (e.g. Statutory Audit Directive, in terms of independence of the external auditors, non-audit services provided, fee cap management and activities / composition of the Audit Committee). Governance & Reporting- Prepare high-quality audit reports for senior management and the Audit Committee;- Provide regular updates on audit progress, key findings, risk themes, and other relevant findings, e.g. those raised by external audit, IAB, etc.;- Ensure independence and objectivity of the Internal Audit function at all times. KEY REQUIREMENTSExperience- Significant experience in internal audit within banking or financial services.- Proven leadership experience, ideally as a Head of Audit or a senior audit leader.- Strong knowledge of commercial banking operations, products and risk frameworks.- Experience working within a UK regulated environment. Qualifications- Professional certification such as CIA, ACA, ACCA, or equivalent.- Degree in Finance, Accounting, Business, or a related discipline. Skills & Competencies- Strong analytical and risk assessment skills.- Excellent communication and stakeholder management abilities.- High level of integrity, independence, and professional judgement.- Ability to influence at Board and Executive level.- Strategic thinking combined with hands-on execution capability.- Time and staff management skills. Desirable- Experience in a foreign bank or international financial institution in London.- Familiarity with cross-border regulatory frameworks.- Experience interacting directly with regulators.-Certain experience in IT and cybersecurity auditing will be given priority. Additional Information- The role is subject to the UK Senior Managers & Certification Regime (SMCR).- The individual must demonstrate fitness and propriety in line with regulatory expectations. Managing the Team:- Recruit and maintain sufficiency and appropriateness of human resources in accordance with agreed plans, and train, develop and lead resources to ensure that targets are met. Manage performance of staff and ensure appropriate training needs are identified. Regulated activities: This section is to be completed for roles that will be covered by the Senior Managers and Certification Regime i.e.: Senior management function (SMF) - one that involves the person performing it being responsible for managing one or more aspects of the firm's affairs, so far as it relates to regulated activities, and those aspects involve, or might involve, a risk of serious consequence for the person, or for the firm or for other interests in the UK. The Prescribed Responsibilities and Other Responsibilities are as set out in the Statement of Responsibilities and the Responsibilities Management Map. Certification - one where the person could pose a risk of significant harm to the firm or any of its customers: Material risk-taker: Advising on, dealing (as principal or agent) and arranging (bringing about) deals in and/or managing investments Giving advice to clients in connection with corporate finance business and performing other functions relating to this. Where direct reports include staff within the Certification population role holder is a voting member of the Credit Committee. Please also provide details of the regulated products that the role holder will be involved in selling/providing advice - N/A The incumbent must comply with the requirements under the Senior Managers and Certification Regime. For Head of Internal Audit:Prescribed Responsibilities - None assigned.SMF - SMF 5 designation is held. Responsibilities of SMF 5 are to be discharged effectively.Conduct Rules - To perform in accordance with the Conduct Rules.
Jun 25, 2026
Full time
London-Based International Corporate Bank: looking to make a vital hire as Head of Internal Audit, small team Head of Internal Audit - International Corporate Bank Main Responsibilities & Accountabilities:Leadership & Strategy- Review the existing audit methodology to develop and execute a risk-based internal audit strategy;- Prepare and regularly update the annual Audit Plan for submission to London Branch Audit Committee and the Head Office Internal Audit Bureau (IAB) for approval.- Lead, mentor and manage the Internal Audit team, fostering a high-performance culture;- Act as the primary liaison with the Board Audit Committee, presenting audit findings and insights.- Ensure that the External Quality Assessment (EQA) is implemented effectively. Audit & Assurance- Provide independent assurance on the adequacy and effectiveness of internal controls, governance, and risk management;- Oversee the delivery of audit engagements across all business areas, with emphasis on key areas including treasury, lending, operations, IT and Compliance;- Ensure audit work is performed in accordance with professional standards;- Undertake special investigations at the request of the Audit Committee and/or the CEO;- Evaluate the effectiveness of remediation actions and track issue resolution;- Maintain, regularly review and refine relevant audit related policies and procedures (e.g. Audit Manual, Internal Audit Findings Risk Appetite Policy, London Branch Audit Committee Terms of Reference, Auditor Independence Policy);- Maintain an up-to-date "audit universe" for the Bank as the business develops;- Including high level review of bank-wide operational policy and procedure manuals as part of the audit work undertaken;- Consider opportunities to enhance co-operation and interaction with fellow group entities wherever possible;- Complete mandatory training as required, and undertake other necessary training to ensure an appropriate level of technical knowledge is maintained;- Oversee the effective deployment of the Internal Audit Management System to maximise benefits; Risk Management & Compliance- Assess emerging risks and adjust audit plans accordingly;- Maintain strong awareness of UK regulatory expectations (e.g. PRA, FCA requirements);- Co-ordinate with Compliance, Risk and external auditors to ensure effective coverage and minimal duplication;- Support regulatory reviews and inspections, as required. Stakeholder Management- Build strong relationships with Senior Management and business heads;- Maintain a good relationship with IAB and ensure that IAB requests are managed on an effective and timely basis;- Provide constructive challenge and actionable recommendations to improve business processes;- Communicate complex risk and control issues clearly to both technical and non-technical stakeholders;- Act as secretary to the London Branch Audit Committee, and facilitate the effective and efficient workings of the London Branch Audit Committee;- Work with the Chairman of the Audit Committee to ensure that relevant regulatory regulations are complied with (e.g. Statutory Audit Directive, in terms of independence of the external auditors, non-audit services provided, fee cap management and activities / composition of the Audit Committee). Governance & Reporting- Prepare high-quality audit reports for senior management and the Audit Committee;- Provide regular updates on audit progress, key findings, risk themes, and other relevant findings, e.g. those raised by external audit, IAB, etc.;- Ensure independence and objectivity of the Internal Audit function at all times. KEY REQUIREMENTSExperience- Significant experience in internal audit within banking or financial services.- Proven leadership experience, ideally as a Head of Audit or a senior audit leader.- Strong knowledge of commercial banking operations, products and risk frameworks.- Experience working within a UK regulated environment. Qualifications- Professional certification such as CIA, ACA, ACCA, or equivalent.- Degree in Finance, Accounting, Business, or a related discipline. Skills & Competencies- Strong analytical and risk assessment skills.- Excellent communication and stakeholder management abilities.- High level of integrity, independence, and professional judgement.- Ability to influence at Board and Executive level.- Strategic thinking combined with hands-on execution capability.- Time and staff management skills. Desirable- Experience in a foreign bank or international financial institution in London.- Familiarity with cross-border regulatory frameworks.- Experience interacting directly with regulators.-Certain experience in IT and cybersecurity auditing will be given priority. Additional Information- The role is subject to the UK Senior Managers & Certification Regime (SMCR).- The individual must demonstrate fitness and propriety in line with regulatory expectations. Managing the Team:- Recruit and maintain sufficiency and appropriateness of human resources in accordance with agreed plans, and train, develop and lead resources to ensure that targets are met. Manage performance of staff and ensure appropriate training needs are identified. Regulated activities: This section is to be completed for roles that will be covered by the Senior Managers and Certification Regime i.e.: Senior management function (SMF) - one that involves the person performing it being responsible for managing one or more aspects of the firm's affairs, so far as it relates to regulated activities, and those aspects involve, or might involve, a risk of serious consequence for the person, or for the firm or for other interests in the UK. The Prescribed Responsibilities and Other Responsibilities are as set out in the Statement of Responsibilities and the Responsibilities Management Map. Certification - one where the person could pose a risk of significant harm to the firm or any of its customers: Material risk-taker: Advising on, dealing (as principal or agent) and arranging (bringing about) deals in and/or managing investments Giving advice to clients in connection with corporate finance business and performing other functions relating to this. Where direct reports include staff within the Certification population role holder is a voting member of the Credit Committee. Please also provide details of the regulated products that the role holder will be involved in selling/providing advice - N/A The incumbent must comply with the requirements under the Senior Managers and Certification Regime. For Head of Internal Audit:Prescribed Responsibilities - None assigned.SMF - SMF 5 designation is held. Responsibilities of SMF 5 are to be discharged effectively.Conduct Rules - To perform in accordance with the Conduct Rules.
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!
