Bethesda Categories:
Senior Data Manager Cardiocore Lab
THIS JOB HAS EXPIRED
The Senior Data Manager, under limited supervision, has responsibility for supporting the departmental Mission of providing clinical project data to internal and external Cardiocore customers in accordance with agreed upon Data Transfer Specification, in compliance with Cardiocore Quality System Procedures and after critically assessing quality of each deliverable. The Senior Data Manager participates in project initiation, conduct, and closing activities that include, but are not limited to, project-specific document preparation, internal and external team meetings, customer communication, and on-going monitoring of the quality of data for the assigned projects. Senior Data Manager is considered a subject matter expert in overall data management process at Cardiocore as well as expert and adviser to the internal team on all matters related to dataset preparation, quality control, and delivery to the client. The incumbent also liaisons with external data management teams to coordinate setup and delivery of ECG data according to specified format, time, and delivery type.Responsibilities:
The Senior Data Manager is responsible for daily oversight of activities as well as assistance in setting up priorities for a group of Data Technicians performing data clean up activities. Daily duties will include but may not be limited to:
Data Specification
Providing detailed operational input into project planning, focusing on data specifications and data management concerns
Working directly with customers on definition and/or review of data specifications through test data transfer and approval
Having a shared responsibility of managing schedule of data transfers
Assisting in defining database set-up and testing to ensure desired results can be achieved
Coordinating all processes required to produce accurate, confidential and retrievable clinical data
Dataset preparation
Coordinating dataset preparation process, including generating datasets, quality control review of output, and resolution of queries from dataset recipients
Providing oversight for the group of Data Technicians by conducting regular status meetings to review daily workload and managing assignments
Assisting Project Managers in maintaining compliant project files as applicable to the Data Manager?s role
Data management processes and technology
Collaborating and coordinating with others in the design, documentation, testing and implementation of clinical data management systems and procedures, and clinical database review
Supporting implementation of technology-enabled processes, working in partnership with other internal groups
Data standards
Developing and documenting data standards, specifications and procedures
Designing and testing data validation logic checks
Experience:
Three (3) to five (5) years experience in clinical trial data management for multiple clinical trials, including large multi-center trials, preferably in a CRO, pharmaceutical or biotech environment
Skills:
Thorough understanding of clinical data management processes and issues, clinical study objectives and methodologies
Knowledgeable about data and file structures, database design and output options
Demonstrable expertise with applicable regulatory guidance and rules, e.g., GCP, ICH E14, 21 CFR Part 11, FDA guidance
Proficient in use of computer systems, including Microsoft Office applications such as Excel, Word, PowerPoint, and relevant systems used in processing clinical data
Good project management and organization skills
Demonstrated ability to communicate verbally and in writing, and interact effectively with internal and external customers
Familiarity with clinical data management systems, tools such as SAS
Education:
BA/BS degree in a technical, business or scientific discipline
Data analysis experience, particularly definition and specification of data structures, database design concepts and data output options
| Location: | 6901 Rockledge Drive Suite 700 Bethesda, MD 20817 United States |
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THIS JOB HAS EXPIRED
Cardiocore Lab
Investors: Aperture Venture Partners, Maryland DBEDAll Jobs: at Cardiocore Lab
| Web Site: | www.cardiocore.com |
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| Headquarters: | 6901 Rockledge Drive Suite 700 Bethesda, MD 20817 United States |
| Industry: | Healthcare Services |
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