1057 clinical quality lead jobs found

argenx Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 1.PURPOSE OF THE FUNCTION Drive towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing Provide GCP oversight for an argenx asset (applicable based on...

argenx Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 1.PURPOSE OF THE FUNCTION Drive towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing Provide GCP oversight for an argenx asset (applicable based on...

argenx Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 1.PURPOSE OF THE FUNCTION Drive towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing Provide GCP oversight for an argenx asset (applicable based on...

argenx Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 1.PURPOSE OF THE FUNCTION Drive towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing Provide GCP oversight for an argenx asset (applicable based on...

argenx Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 1.PURPOSE OF THE FUNCTION Drive towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing Provide GCP oversight for an argenx asset (applicable based on...

argenx Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 1.PURPOSE OF THE FUNCTION Drive towards real time quality oversight and consistent high-quality standards of the global clinical trials, both pre and post marketing Provide GCP oversight for an argenx asset (applicable based on...

Shields Health Solutions Patient Support Supervisor Location: Stoughton and Phoenix Area Preferred (other locations considered based on unique situations) Shields is seeking an experienced person who loves to work with and lead people, has strong management skills, who is highly motivated self-starter who is looking for a challenging career with a fast-growing company in specialty pharmacy management services. Applicants should be results-oriented with a positive outlook and a clear focus on high quality. A natural forward planner who critically assesses their own performance. The ideal candidate should have front-line employee management experience with a background in pharmacy or healthcare. Applicant should be service-oriented, motivational in their style and have a clear focus on performance accountability and employee development. The applicant must be able to work as a member of a close-knit team. A Patient Support Supervisor is a key leadership position supporting...

UNC Health Description ***Up to $20,000.00 Commitment Incentive!!** Summary: The Medical Technologist performs a wide variety of complex critical tests and analyses in the areas of Blood Banking, Clinical Chemistry, Coagulation, Hematology, Immunology, Microbiology and Parasitology which provide clinical information for the diagnosis, treatment and prevention of diseases. Responsible for overall quality, efficiency, and safety in the performance of assigned technical duties. The Medical Technologist performs a wide variety of complex critical tests and analyses in the areas of Blood Banking, Clinical Chemistry, Coagulation, Hematology, Immunology, Microbiology and Parasitology which provide clinical information for the diagnosis, treatment and prevention of diseases. Responsible for overall quality, efficiency, and safety in the performance of assigned technical duties. Responsibilities: 1. Performs tests on patient samples, completing complex critical...

UNC Health Description ***Up to $20,000.00 Commitment Incentive!!** Summary: The Medical Technologist performs a wide variety of complex critical tests and analyses in the areas of Blood Banking, Clinical Chemistry, Coagulation, Hematology, Immunology, Microbiology and Parasitology which provide clinical information for the diagnosis, treatment and prevention of diseases. Responsible for overall quality, efficiency, and safety in the performance of assigned technical duties. The Medical Technologist performs a wide variety of complex critical tests and analyses in the areas of Blood Banking, Clinical Chemistry, Coagulation, Hematology, Immunology, Microbiology and Parasitology which provide clinical information for the diagnosis, treatment and prevention of diseases. Responsible for overall quality, efficiency, and safety in the performance of assigned technical duties. Responsibilities: 1. Performs tests on patient samples, completing complex critical...

UNC Health Description ***Up to $20,000.00 Commitment Incentive!!** Summary: The Medical Technologist performs a wide variety of complex critical tests and analyses in the areas of Blood Banking, Clinical Chemistry, Coagulation, Hematology, Immunology, Microbiology and Parasitology which provide clinical information for the diagnosis, treatment and prevention of diseases. Responsible for overall quality, efficiency, and safety in the performance of assigned technical duties. The Medical Technologist performs a wide variety of complex critical tests and analyses in the areas of Blood Banking, Clinical Chemistry, Coagulation, Hematology, Immunology, Microbiology and Parasitology which provide clinical information for the diagnosis, treatment and prevention of diseases. Responsible for overall quality, efficiency, and safety in the performance of assigned technical duties. Responsibilities: 1. Performs tests on patient samples, completing complex critical...

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

CSL The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions, and is accountable for the statistical deliverables within the program. Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents. Provide statistical thought partnership for innovative study design and clinical development...

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

CSL The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions, and is accountable for the statistical deliverables within the program. Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area. Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews. Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents. Provide statistical thought partnership for innovative study design and clinical development...

CSL 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. Could you be our next Principal, Statistical Programmer? The job is in our King of Prussia, PA or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. You will be a member of the Biostatistics team and plays a lead role in performing all statistical programming tasks required for clinical trial analysis and reporting. This position works closely with other members of the BDPM on various clinical projects. During clinical trial from start up to the end of the clinical data analysis/report, the incumbent will be responsible for planning, preparing, managing, coordinating and performing...

CSL 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 Associate Director Clinical Operations Lead is accountable for the development of the operational strategy for a clinical study(ies) and/or a clinical program (s) as well as the end-to-end study management and delivery of all operational activities and budget management relating to assigned clinical study (ies)/program(s). This role must be experienced in working in a matrix environment (internal and external partners) with cross-functional responsibilities associated with trial execution and overall therapeutic area clinical development planning. This role typically manages one or more studies/or products, often...

CSL The Director, Statistical Programming provides leadership and expertise in driving the development and maintenance of the CSL statistical programming capabilities which is required to meet regulatory obligations. Manages a team of programmers supporting clinical trial and integrated analyses, annual reporting, regulatory responses, publications, HTA requests and other purposes as needed within one or more therapeutic areas. The individual will work closely with the Senior Director, Clinical and Statistical Programming to advance the internal programming environment and statistical programming processes. Works closely with Statisticians to ensure that deliverables provided by internal resources or outside providers (CROs; FSP providers) are accurate and aligned with CSL standards. Main Responsibilities Working with the Biometrics Programming Leadership team, assess upcoming activities and resulting resource needs and allocate projects to people to ensure high...

CSL 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. Could you be our next Principal, Statistical Programmer? The job is in our King of Prussia, PA or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. You will be a member of the Biostatistics team and plays a lead role in performing all statistical programming tasks required for clinical trial analysis and reporting. This position works closely with other members of the BDPM on various clinical projects. During clinical trial from start up to the end of the clinical data analysis/report, the incumbent will be responsible for planning, preparing, managing, coordinating and performing...