Clinical Data Manager
Medina, WA · On-site
The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate ...
61 Tempus Clinical Data Manager Jobs Hiring Near You
Clinical Data Manager
Medina, WA · On-site
The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate ...
Tempus Jobs Information
What are the key skills and qualifications needed to thrive as a Clinical Data Manager, and why are they important?
To thrive as a Clinical Data Manager, you need a solid understanding of clinical research processes, data management principles, and a degree in life sciences, computer science, or related fields. Expertise with clinical data management systems (CDMS), electronic data capture (EDC) tools, and familiarity with regulatory standards like CDISC and GCP are typically required. Attention to detail, problem-solving abilities, and effective communication distinguish top performers in this role. These skills ensure accurate, compliant data handling and seamless collaboration across clinical research teams, which are critical for successful clinical trial outcomes.
What are some common challenges Clinical Data Managers face when working on multi-site clinical trials?
Clinical Data Managers often encounter challenges such as ensuring data consistency across different sites, managing large volumes of complex data, and coordinating with site staff to resolve discrepancies. They must also stay up-to-date with regulatory requirements and ensure timely data cleaning and database lock. Effective communication and strong organizational skills are essential to navigate these complexities and maintain high data quality throughout the study.
What does a Clinical Data Manager do?
A Clinical Data Manager is responsible for collecting, validating, and managing data from clinical trials to ensure its accuracy, integrity, and compliance with regulatory standards. They design data collection systems, oversee database development, and collaborate with clinical research teams to resolve data discrepancies. By ensuring high-quality data, Clinical Data Managers play a vital role in the success of clinical trials and the development of new medical treatments.
What is it like to work at Tempus?
Tempus is a data-driven healthcare technology company that prioritizes innovation and collaboration, fostering a culture of teamwork and continuous learning.
The company's structure is designed to facilitate interdisciplinary collaboration, with teams comprising experts from various fields, including medicine, engineering, and data science, working together to develop and implement cutting-edge technologies that improve cancer care and patient outcomes.
Working at Tempus may appeal to individuals who are passionate about using data and technology to drive meaningful change in healthcare, as the company offers opportunities for professional growth, a dynamic work environment, and the chance to contribute to a mission that has the potential to impact millions of lives.
The company's structure is designed to facilitate interdisciplinary collaboration, with teams comprising experts from various fields, including medicine, engineering, and data science, working together to develop and implement cutting-edge technologies that improve cancer care and patient outcomes.
Working at Tempus may appeal to individuals who are passionate about using data and technology to drive meaningful change in healthcare, as the company offers opportunities for professional growth, a dynamic work environment, and the chance to contribute to a mission that has the potential to impact millions of lives.
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Job description
Job Description:
The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock. The CDM ensures that data is accurate, consistent, and meets regulatory and protocol-specific requirements. This role collaborates closely with cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution.
Responsibilities:
- Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture aligned with the study protocol.
- Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines.
- Oversee data cleaning activities, including the generation, review, and resolution of data queries in collaboration with clinical sites and study teams.
- Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations.
- Ensure adherence to data standards (e.g., CDISC, SDTM) and regulatory requirements (e.g., FDA, ICH-GCP).
- Manage database lock activities and contribute to the preparation of clinical study reports (CSRs).
- Serve as the primary point of contact for data management vendors and oversee their deliverables.
- Participate in study team meetings and provide status updates related to data quality and timelines.
- Support audit readiness and participate in regulatory inspections when required.
Requirements:
- Bachelor's degree in Life Sciences, Computer Science, Health Informatics, or related field. Advanced degree is a plus.
- Minimum of 3-5 years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment.
- Proficiency in EDC platforms (e.g., Medidata Rave, Oracle Inform , Veeva, Redcap).
- Strong understanding of ICH-GCP, FDA regulations, and CDISC standards.
- Experience with data listings, query management, edit check programming, and coding dictionaries (e.g., MedDRA, WHO Drug).
- Excellent organizational, analytical, and problem-solving skills. Strong communication and collaboration skills across cross-functional teams.
- Experience working on global, multi-site clinical trials preferred.