Join to apply for the Lead Clinical Data Manager role at Katalyst CRO We are seeking a Lead Clinical Data Manager to lead and manage clinical data management activities for oncology clinical trials. Responsibilities Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards. Provide strategic oversight and direction to CRO clinical data management teams for assigned studies. Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements. Oversee the design, build, and validation of clinical databases using Medidata Rave EDC, ensuring optimal configuration and functionality. Conduct thorough reviews of clinical data, identifying trends, inconsistencies, and potential issues that may impact data quality or study outcomes. Collaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignment of data management strategies with overall clinical development goals. Provide oversight, and performance management of external data management vendors. Maintain SOPs, guidelines, and best practices for clinical data management processes. Represent the Clinical Data Management function in internal and external meetings, providing expert guidance on data-related matters. Stay current with industry trends, regulatory requirements, and technological advancements in clinical data management, particularly in the oncology field. Requirements Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred. A minimum of 7+ years of clinical data management experience in the biotechnology or pharmaceutical industry. Experience managing oncology clinical trials data, including a deep understanding of oncology-specific data requirements and challenges. Expert-level proficiency with Medidata Rave EDC, including system configuration, form design, and edit check programming. Strong knowledge of clinical research processes, FDA & ICH guidelines, GCP, GCDMP, and CDISC standards. Demonstrated experience in CRO and vendor oversight. Excellent project management skills with the ability to manage multiple studies simultaneously. Strong analytical and problem-solving skills with meticulous attention to detail. Outstanding communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders. Proficiency in Microsoft Office Suite and familiarity with statistical software (e.g., SAS, R) is a plus. CCDM (Certified Clinical Data Manager) certification. Experience with risk-based monitoring in oncology studies. Knowledge of emerging technologies in clinical data collection and management (e.g., ePRO, wearables, AI/ML applications). Katalyst CRO is an equal opportunities employer. #J-18808-Ljbffr Katalyst CRO
...About the job Data Entry Assistant (Junior / Remote) CHECK YOUR EMAIL, INCLUDING YOUR SPAM FOLDER, FOR INSTRUCTIONS AFTER APPLYING... ...and an eye for detail? If so, we have the perfect entry-level opportunity for you as a Remote Data Entry Operator at our company...
At Cargill, we are dedicated to improving the global food system. In the role of HACCP (Hazard Analysis Critical Control Point) Associate... ...both production teams and quality assurance to develop and implement effective food safety plans that align with regulatory compliances.
...you pull the orders and deposit them into your tote. Once your picklist is complete. You will then take the tote and hand it to a packing station to package the order. Candidates will be asked to float and a package station position. The job duties of the package station...
...Job Description Job Description Entry Level Associate Attorney - San Diego, CA Salary $80K - $100K Summary Reese Law Group... ...Reese Law Group, in Carlsbad, CA. Physical, Mental, and Environmental Demands Must be able to work in a seated or standing position...
...raw material inventories to ensure supply. The Amgen Rhode Island location consists of a grown, large-scale production plant that produces 10 different biologic products and a Manufacturing of the Future (MoF) single-use technology plant that was recently approved for...