45 senior manager clinical data management jobs found

As an integral part of a study, the statistical programmer provides project leadership and programming support for processing data from clinical studies. Requirements will be identified according to a Statistical Analysis Plan and programming specifications using internal standards and guidelines. In this role, a typical day might include the following: Assist in providing mentorship in implementing and driving the programming and project standards. The evaluation and development of study requirements and validation plan are also in the scope of this position. Design and test program logic, coding programs, program documentation and preparation of programs. Coordinates projects crafted to support ongoing clinical studies requests for statistical and non-statistical analyses. Meets statistical adhoc requests of senior management. Provides documentation and consistent maintenance of code, logs, and output in a regulated environment. Support and/or lead programmer for...

The Manager QA Validation is responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regeneron’s Raheen facility. A typical day might include, but is not limited to, the following:   Designing and developing policies for validation and ensuring that they are effectively administered and comply with regulatory requirements Leading all aspects of QA validation including reviewing and approving of the following types of documents, relating to area functions: Failure investigations, Change controls and associated Test Plan documentation, SOPs, Validation protocols and summary reports, Validation Master Plans Managing Validation Department personnel by developing validation work plans, establishing objectives, and assigning tasks Developing and managing validation budget, contracts, and schedules Presenting and defending validation data to FDA and other regulatory agencies Maintaining validation...

The Senior Statistical Programmer provides support to the lead programmer and study team on all programming activities according to the study requirements and the timelines. This role contributes to studies in various therapeutical areas and all clinical trial phases. The incumbent implements and executes the programming and project standard under minimal supervision of the lead programmer and manager to support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. Maintains programming documentations such as study tracker, code, logs, and outputs in a regulated environment.   In this role, a typical day might include the following:    Provide programming support within multiple studies/projects in various study activities with timely and high-quality programming deliverables in assigned tasks and projects   Demonstrate company values by demonstrating excellence, competence,...

Innovation starts from the heart. At Edwards Lifesciences, we’re dedicated to developing ground-breaking technologies with a genuine impact on patients’ lives. At the core of this commitment is our investment in cutting-edge information technology. This supports our innovation and collaboration on a global scale, enabling our diverse teams to optimize both efficiency and success. As part of our IT team, your expertise and commitment will help facilitate our patient-focused mission by developing and enhancing technological solutions. We are looking to hire an experienced front-end Salesforce Developer proficient in front-end and back-end configuration and development to join our dynamic global team.  This person will be responsible for maintaining and updating the code base related to Edwards’ global Salesforce application, a mission-critical app used by our field sales teams to further our ability to deliver devices that maximize our patient’s recovery and quality of life.   You...

What Business Analysis contributes to Cardinal Health Information Technology oversees the effective development, delivery, and operation of computing and information services. This function anticipates, plans, and delivers Information Technology solutions and strategies that enable operations and drive business value. Business Analysis serves as a liaison between the organization's businesses and IT systems development teams to align business strategies and capability needs and to ensure IT systems enable their desired value. This job family identifies and analyzes business needs, defines requirements and objectives, and makes recommendations for solutions using new and existing technologies. This job family researches and documents relationships between the components of the application system (i.e., end users, business processes, data, applications, and devices) and translates business requirements into application requirements. Job Summary Partners with business leaders...

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you. The Customer Success Manager (CSM) is responsible for managing the technical aspects of McKesson’s relationship with its clients. The role involves onboarding, training, account management, and proactive support for McKesson’s RetinaOS Inventory Management System. The CSM works with clients to drive adoption and optimize user experience. This individual will focus on...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Career Category Manufacturing Job Description Description: Flexible Commuter Must have skills: Project management. Technical writing. Understanding of Good Manufacturing Practices in the Biopharmaceutical, Pharmaceutical, or Medical Device industries. Experience or knowledge of operations (in the three industries listed above). Quality management skills including previous experience managing quality records in Trackwise, Veeva or a comparable quality system. Previous experience in inventory management systems such as SAP. Job Description: The Specialist, Manufacturing will serve as the primary point of contact and external supply quality record owner for Amgen’s sites in Ireland (Dun Laoghaire) and the Netherlands (Breda). The main responsibility of this role is to manage quality records for events associated with the Secondary Packaging and Device categories, while also providing support for events in additional categories as needed. This support includes...

Career Category Engineering Job Description The Specialist IS Engineer will assist in designing, developing, and maintaining applications and associated data engineering solutions that meet business needs and ensuring the availability and performance of critical systems. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable solutions and automating operations, monitoring system health, and responding to incidents to minimize downtime. You will be part of a team specifically focused on Amgen’s Commercialization business. Amgen is using fully integrated and best-in-class technologies, having various enterprise platforms such as AWS, Databricks, Salesforce, Planisware and Anaplan; enterprise collaboration platforms such as O365, SharePoint Online and MS Teams, as well as vertical-specific platforms in R&D, Operations, Process Development and Commercial/Marketing areas. This role will manage the Amgen...

Career Category Information Systems Job Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: Let’s do this. Let’s change the world. Part of the Artificial Intelligence & Data function of the Amgen Technology and Medical Organizations (ATMOS), the AI & Data Innovation Lab (the Lab) is the centre for exploration and innovation, focused on integrating and accelerating new technologies and methods that deliver measurable value and competitive advantage. We’ve built algorithms that predict bone fractures in patients who haven’t...

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To...

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career....

Career Category Quality Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career....

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH.   Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c).   Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration....

Career Category Information Systems Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your...

Career Category Information Systems Job Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLE Role Description: The Software Engineer is responsible for designing, developing, and maintaining software applications and solutions that meet business needs and ensuring the availability and performance of critical systems and applications. This role involves working closely with product managers, designers, and other engineers to create high-quality, scalable software solutions and automating operations, monitoring system health, and responding to...

Career Category Information Systems Job Description About the Role We are seeking a Software Engineer to join our Digital Manufacturing team, collaborating with developers and technical specialists. This position plays a critical role in the development, implementation, and maintenance of our Manufacturing Systems, which is integral to our strategy for modernizing industrial systems. As part of our Technology organization, you will collaborate with a global team of engineers, automation specialists, IT professionals, and operations teams to deliver robust, scalable, and compliant Manufacturing solutions. You’ll contribute to the transformation of our industrial network, leveraging modern technologies and integrating Manufacturing with enterprise systems. Roles & Responsibilities Contribute to the design, software development, deployment and maintenance of the capabilities to integrate Manufacturing data. Develop new features for IoT platform, supporting...

Career Category Engineering Job Description About the Role We are seeking a Software Engineer to join our Industrial IoT team, collaborating with developers and technical specialists. This position plays a critical role in the development, implementation, and maintenance of our IoT platform, which is integral to our strategy for modernizing industrial systems. As part of our Technology organization, you will collaborate with a global team of engineers, automation specialists, IT professionals, and operations teams to deliver robust, scalable, and compliant IoT solutions. You’ll contribute to the transformation of our industrial network, leveraging modern technologies and integrating IoT with enterprise systems. Roles & Responsibilities Contribute to the design, software development, deployment and maintenance of the industrial IoT platform. Develop new features for IoT platform, supporting business use cases/goals and integrating the platform with new data...

Career Category Engineering Job Description About the Role We are seeking a Software Engineer to join our Industrial IoT team, collaborating with developers and technical specialists. This position plays a critical role in the development, implementation, and maintenance of our IoT platform, which is integral to our strategy for modernizing industrial systems. As part of our Technology organization, you will collaborate with a global team of engineers, automation specialists, IT professionals, and operations teams to deliver robust, scalable, and compliant IoT solutions. You’ll contribute to the transformation of our industrial network, leveraging modern technologies and integrating IoT with enterprise systems. Roles & Responsibilities Contribute to the design, software development, deployment and maintenance of the industrial IoT platform. Develop new features for IoT platform, supporting business use cases/goals and integrating the platform with new data...

Career Category Information Systems Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your...