Lead Clinical Data Manager
Irvine, CA · On-site
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 ...
Katalyst Data Management
60 Katalyst Data Management Jobs Hiring Near You
Lead Clinical Data Manager
Irvine, CA · On-site
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 ...
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 ...
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 ...
Lead Clinical Data Manager
Durham, NC · On-site
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 ...
Lead Clinical Data Manager
Durham, NC · On-site
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 ...
Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs * Provide leadership to the team in ...
Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs * Provide leadership to the team in ...
Lead Clinical Data Manager
Boston, MA · On-site
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 ...
Lead Clinical Data Manager
Boston, MA · On-site
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 ...
Lead clinical data management activities for pivotal trials, ensuring data quality and integrity * Collaborate with cross-functional teams to support clinical trial data management processes
Lead clinical data management activities for pivotal trials, ensuring data quality and integrity * Collaborate with cross-functional teams to support clinical trial data management processes
Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs * Provide leadership to the team in ...
Provide comprehensive data management expertise to Clinical Data Management (CDM) team to provide high quality data management products that meet customer needs * Provide leadership to the team in ...
Sr. Clinical Data Manager
Round Lake, IL · On-site
Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements * Design case ...
Sr. Clinical Data Manager
Round Lake, IL · On-site
Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements * Design case ...
Represent Data Management in study team meetings, providing metrics and guidance on data-related issues. * Oversee Data Management activities from study start-up to close-out. * Develop and manage ...
Represent Data Management in study team meetings, providing metrics and guidance on data-related issues. * Oversee Data Management activities from study start-up to close-out. * Develop and manage ...
Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. * Lead database build activities including leading cross-functional review of eCRF content ...
Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. * Lead database build activities including leading cross-functional review of eCRF content ...
Work is reviewed with the Data Management Leaders, or the immediate manager as needed * Take a leadership role with external suppliers, trial customers and other internal/external partners to ...
Work is reviewed with the Data Management Leaders, or the immediate manager as needed * Take a leadership role with external suppliers, trial customers and other internal/external partners to ...
Sr. Clinical Data Manager
Danbury, CT · On-site
Represent Data Management in study team meetings, providing metrics and guidance on data-related issues. * Oversee Data Management activities from study start-up to close-out. * Develop and manage ...
Sr. Clinical Data Manager
Danbury, CT · On-site
Represent Data Management in study team meetings, providing metrics and guidance on data-related issues. * Oversee Data Management activities from study start-up to close-out. * Develop and manage ...
Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. * Lead database build activities including leading cross-functional review of eCRF content ...
Lead data management activities as a program-level lead data manager in support of Alnylam clinical studies. * Lead database build activities including leading cross-functional review of eCRF content ...
Clinical Data Manager
Charlotte, NC · On-site
Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized ...
Clinical Data Manager
Charlotte, NC · On-site
Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized ...
Clinical Data Manager
Boulder, CO · On-site
Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks * Provide study level metrics/reports and external data reconciliation ...
Clinical Data Manager
Boulder, CO · On-site
Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks * Provide study level metrics/reports and external data reconciliation ...
Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines * Oversee data cleaning activities, including the generation, review, and resolution ...
Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines * Oversee data cleaning activities, including the generation, review, and resolution ...
Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized ...
Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized ...
Clinical Data Manager
Chicago, IL · On-site
Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized ...
Clinical Data Manager
Chicago, IL · On-site
Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), CRF Completion Guidelines, Edit Checks, UAT specifications, centralized ...
Regularly monitor data management costs of the assigned studies ensuring respect of budget. * Define and proactively manage risks with potential impact on study systems setup, study conduction, or ...
Regularly monitor data management costs of the assigned studies ensuring respect of budget. * Define and proactively manage risks with potential impact on study systems setup, study conduction, or ...
In this pivotal role, you will oversee the collection, management, and validation of clinical trial data to ensure accuracy, integrity, and compliance with regulatory standards. Your expertise will ...
In this pivotal role, you will oversee the collection, management, and validation of clinical trial data to ensure accuracy, integrity, and compliance with regulatory standards. Your expertise will ...
Katalyst Data Management Jobs Information
Job description
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.
- 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)