Clinical Data Manager
The Clinical Data Manager (CDM) at eClinical Solutions plays a pivotal role in supporting study teams by developing comprehensive study documentation, designing database specifications, and overseeing validation, maintenance, data cleaning, and closeout activities for clinical trial databases. As a platform expert, the CDM leverages cutting-edge tools and technologies to provide continuous data insights, ensuring the timely delivery of high-quality results for sponsors. This position requires a strong foundation in clinical data management, coupled with the agility to adapt to evolving processes integrating clinical data science.
Key responsibilities include defining project specifications for data management services such as protocol conversion, database build, CRF design, and data review tools. The CDM is expected to understand external data collection and its integration into clinical trials, executing data cleaning strategies to accelerate subject data cleanliness. Additionally, the role involves performing holistic data review and trending analysis using reporting and analytics tools to proactively identify issues and develop mitigation strategies. Utilizing artificial intelligence and machine learning for anomaly detection is also a critical aspect of the position.
Candidates should possess at least 5 years of experience in clinical data management, preferably with a bachelor's degree in a health-related field. Strong project management and team leadership skills are essential, along with excellent analytical and strategic thinking abilities. Proficiency in Microsoft Office applications, knowledge of ICH/GCP guidelines, and experience with EDC and clinical data management systems are required. Familiarity with cloud SaaS platforms, data reporting tools, and risk-based quality management methodologies is preferred.
eClinical Solutions offers a dynamic work environment that fosters professional growth and development. Employees have the opportunity to work with innovative technologies and contribute to the advancement of healthcare through improved clinical data management. The company values diversity and inclusivity, providing a supportive culture where team members can thrive and make a meaningful impact.