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
...Associates, Inc. (AMT, Inc.) is hiring Transportation Construction Inspectors to support projects throughout various WVDOH Districts and... ...asset is our staff. For 70 years, we have worked diligently to build a team of talented employees who fully embody our values as an...
...SUMMARY OF POSITION: We are seeking a dynamic and detail-oriented Marketing Coordinator to join our marketing team. In this role, you will... ...will have a proven track record in campaign management, content creation, and cross-functional coordination, with strong organizational...
...Job Description Job Description Job Title: Endocrinologist Job Summary: We are seeking a board-certified or board-eligible Endocrinologist to provide comprehensive care for patients with endocrine and metabolic disorders. The physician will evaluate, diagnose...
...refinement of neighborhoods meets the generosity of Lebanese hospitality. ilili DC, located at The Wharf, is seeking an experienced Sommelier to join the team! As a Sommelier at ilili, you are an ambassador of Lebanese hospitality who provides timely, friendly service...
...Job Description GQR Healthcare is seeking a travel nurse RN Wound Care for a travel nursing job in Los Angeles, California. Job Description & Requirements ~ Specialty: Wound Care ~ Discipline: RN ~ Start Date: 02/04/2026~ Duration: 13 weeks ~40 hours...