Data Management CRO Oversight Responsible for the oversight of all data management CRO activities supporting companys clinical programs from database start-up through database lock and CSR/submission. Serves as primary point of contact with the DM CROs, 3rd party vendors
Job Description Provide engineering support for Heating, Ventilation, and Air Conditioning (HVAC) systems to ensure reliable, compliant, and efficient operation of facility and manufacturing environments. This role supports operations, maintenance, and capital projects within Utilities and
Katalyst CRO is seeking an HVAC engineer to provide engineering support for HVAC systems in pharmaceutical facilities, ensuring reliable, compliant, and efficient operation across utilities and facilities. You will work with operations, maintenance, and capital projects to maintain
Katalyst CRO in Bothell, WA seeks an experienced Manufacturing Quality professional to support quality systems, validation, supplier quality, and production transfer activities during a regulated manufacturing transfer program. The role emphasizes CAPA, audits, process verification, data collection and
Katalyst CRO seeks an experienced Supplier Quality Engineer in Winston-Salem. This role focuses on supplier quality assurance, development, and new product introduction activities, ensuring compliance with quality standards across various engineering processes. The position requires conducting evaluations, implementing
Responsibilities Drive analytical method validation/ transfer of laboratory methodologies. Support the execution and issue resolution (e.g., discrepancies) and completion approval of test plans/protocols. Support troubleshooting of analytical methods. Ensure laboratory equipment is maintained in a validated
Senior Manager Regulatory Affairs Location: Norcross, GA Salary: $180,000.00 - $220,000.00Responsibilities Support the Senior Director in developing and executing regional regulatory strategies for QOL initiatives within specific regions. Contribute to providing strategic oversight and leadership to
Responsibilities Facilitate audit request process for GxP regulatory inspections, customer audits, and internal quality audits. Develop a strong understanding of SLC and system evidence to support audits. Leverage available resources and improve resources to enhance or
Katalyst CRO is searching for a highly experienced Manager, Regulatory Affairs to join our Regulatory Affairs team in Mossville, Illinois. In this pivotal role, youll ensure compliance with U.S. regulatory requirements and support the development and lifecycle management
A leading healthcare company is seeking a Principal Regulatory Affairs professional to develop regulatory strategies for Companion Diagnostics. The role entails leading global submissions and collaborating with diverse teams to ensure compliance with regulatory standards. Candidates
Katalyst CRO is seeking a Lead Statistician in San Francisco, California. This role requires an individual with strong SAS programming skills and a master’s degree in a related field. You will be responsible for overseeing statistical analyses for
Senior Manager in StatisticsThe Senior Manager in Statistics is responsible for performing statistical activities in clinical trials from protocol development to final study report and statistical activities in drug in-licensing, regulatory filings, and marketing. Responsibilities include:Review
Clinical Data Management Leader Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc. Perform or provide
Clinical Data Manager Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting. Develop and manage data management timelines for multiple projects, ensuring all milestones are met according
A leading contract research organization in Thousand Oaks, California, is seeking an experienced professional for analytical method validation. The role demands at least 7 years of experience in analytical development within pharmaceutical settings, a strong understanding
Clinical Data Management Leader Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc. Perform or provide
Responsibilities Principal Regulatory Affairs is responsible for regulatory strategy development and execution for high‑complexity diagnostics specifically Companion Diagnostics and digital pathology in the clinical oncology environment. Senior Principal, Regulatory Affairs will provide oversight and lead global
A clinical research organization in Chicago is seeking an experienced audit support professional. The role involves facilitating the audit request process for regulatory inspections, conducting data analytics, and implementing process improvements. Candidates should have over 8
Job Description Looking for someone who has leadership skills. Great early role to gain extensive industry experience. SAS programming a MUST. Writes/reviews analysis plans and guides others on the team in its implementation. Defines appropriate methods
Executive Medical Director Of Neurology, Clinical Development The Executive Medical Director of Neurology, Clinical Development holds the responsibility to lead clinical programs across different diseases and supervise the clinical development team. This individual will be the