Katalyst CRO
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Clinical Data Manager
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Katalyst CRO 2 weeks ago Be among the first 25 applicants Join to apply for the
Clinical Data Manager
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Clinical Data Manager, providing oversight to ensure complete, accurate and high-quality data collection for outsourced and in-house trials. Establish and maintain strong relationships with internal cross-functional teams, vendors and clinical research site personnel for successful execution of clinical trial Lead and oversee Electronic Data Capture (EDC) build, migration and deployment including creation and execution of user acceptance testing plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., IRT, laboratory, imaging). Oversee set-up of other clinical management systems (e.g., IxRS) and data transfer agreements with external vendors. Write or contribute to preparation of CDM documents. Lead the development of EDC custom and Business Objective reports, SAS clinical programming report specifications and data visualization output. In collaboration with Study Execution Team, participate in clinical document review such as clinical protocols, statistical analysis plans, protocol deviation plans, mock tables, figures and listings. Report Data Management metrics and trends; identify barriers to timely and successful trial execution and propose solutions.
Responsibilities
Clinical Data Manager, providing oversight to ensure complete, accurate and high-quality data collection for outsourced and in-house trials. Establish and maintain strong relationships with internal cross-functional teams, vendors and clinical research site personnel for successful execution of clinical trial Lead and oversee Electronic Data Capture (EDC) build, migration and deployment including creation and execution of user acceptance testing plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., IRT, laboratory, imaging). Oversee set-up of other clinical management systems (e.g., IxRS) and data transfer agreements with external vendors. Write or contribute to preparation of CDM documents. Lead the development of EDC custom and Business Objective reports, SAS clinical programming report specifications and data visualization output. In collaboration with Study Execution Team, participate in clinical document review such as clinical protocols, statistical analysis plans, protocol deviation plans, mock tables, figures and listings. Report Data Management metrics and trends; identify barriers to timely and successful trial execution and propose solutions.
Requirements:
Bachelor's Degree in life sciences or related discipline, minimum 5+ years of experience in clinical data management or relevant work experience. CRO or CDM vendor management experience in oncology. Early phase adaptive trial management experience preferred. Experience with CDASH terminology and/or MedDRA and Who Drug medical coding. Experience with SAS programming techniques is a plus. Experience with RaveX and/or Veeva EDC is a plus. Strong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines. Proficient on EDC configuration and design, testing and validation, data collection and data review process, and data standardization. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for Clinical Data Manager roles.
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Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Clinical Data Manager
role at
Katalyst CRO 2 weeks ago Be among the first 25 applicants Join to apply for the
Clinical Data Manager
role at
Katalyst CRO Get AI-powered advice on this job and more exclusive features. Clinical Data Manager, providing oversight to ensure complete, accurate and high-quality data collection for outsourced and in-house trials. Establish and maintain strong relationships with internal cross-functional teams, vendors and clinical research site personnel for successful execution of clinical trial Lead and oversee Electronic Data Capture (EDC) build, migration and deployment including creation and execution of user acceptance testing plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., IRT, laboratory, imaging). Oversee set-up of other clinical management systems (e.g., IxRS) and data transfer agreements with external vendors. Write or contribute to preparation of CDM documents. Lead the development of EDC custom and Business Objective reports, SAS clinical programming report specifications and data visualization output. In collaboration with Study Execution Team, participate in clinical document review such as clinical protocols, statistical analysis plans, protocol deviation plans, mock tables, figures and listings. Report Data Management metrics and trends; identify barriers to timely and successful trial execution and propose solutions.
Responsibilities
Clinical Data Manager, providing oversight to ensure complete, accurate and high-quality data collection for outsourced and in-house trials. Establish and maintain strong relationships with internal cross-functional teams, vendors and clinical research site personnel for successful execution of clinical trial Lead and oversee Electronic Data Capture (EDC) build, migration and deployment including creation and execution of user acceptance testing plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., IRT, laboratory, imaging). Oversee set-up of other clinical management systems (e.g., IxRS) and data transfer agreements with external vendors. Write or contribute to preparation of CDM documents. Lead the development of EDC custom and Business Objective reports, SAS clinical programming report specifications and data visualization output. In collaboration with Study Execution Team, participate in clinical document review such as clinical protocols, statistical analysis plans, protocol deviation plans, mock tables, figures and listings. Report Data Management metrics and trends; identify barriers to timely and successful trial execution and propose solutions.
Requirements:
Bachelor's Degree in life sciences or related discipline, minimum 5+ years of experience in clinical data management or relevant work experience. CRO or CDM vendor management experience in oncology. Early phase adaptive trial management experience preferred. Experience with CDASH terminology and/or MedDRA and Who Drug medical coding. Experience with SAS programming techniques is a plus. Experience with RaveX and/or Veeva EDC is a plus. Strong working knowledge of CDISC standards, FDA and ICH/GCP regulations and guidelines. Proficient on EDC configuration and design, testing and validation, data collection and data review process, and data standardization. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Job function
Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Sign in to set job alerts for Clinical Data Manager roles.
Clinical Registry Manager- Hybrid - 134676
Supervisory Health System Specialist (Credentialing and Privileging Manager)
Behavioral Health Care Manager Remote, must be Licensed and Reside in California
Research Nurse (RN) - Hematology Oncology Research Resources
Clinical Research Project Manager, Consultant
Clinical Case Manager-Oncology Navigation Program - Sharp Memorial Hospital - Full-time (1.0) - Days
Senior Business Development Manager, Data Partnerships
Health Services Data Analyst - Sharp Health Plan - Day Shift - Full Time
Health Services Data Analyst - Sharp Health Plan - Day Shift - Full Time
Risk Specialist, Clinical Quality Assurance
Pharmacy Technician-Specialties Sharp Grossmont Specialty Pharmacy Day Shift Per Diem
AI & Data Manager - Life Sciences R&D Clinical (Pharma)
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr