Data Manager

Cardionet Rockville, MD

Overview:

BioTelemetry Research is seeking a Data Manager for our Rockville, Maryland office. The Data Manager, under limited direct supervision, has responsibility for the planning, data specification, data oversight and delivery activities and milestones associated with managing clinical research studies from start-up through final locked database. The 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, clinical trial site and customer communication, and on-going monitoring of the quality of data. The Data Manager, as part of the study project team, is accountable to the Project Manager for study-specific deliverables, and collaborates with other internal groups as well as customer data management representatives to ensure successful data delivery to the customer.

Responsibilities:
  • Working directly with customer data management representatives on definition and/or review of data specifications through test data transfer and approval
  • Assisting in defining database set-up requirements and testing to ensure desired results can be achieved
  • Collaborating with internal groups in the design, documentation, testing and implementation of clinical data management systems and procedures
  • Supporting implementation of technology-enabled processes, working in partnership with other internal groups
  • Implementing data standards, documenting specifications and procedures
  • Designing and testing data validation logic checks
  • Coordinating dataset delivery processes, including dataset generation using previously validated programs, quality control review of output, and resolution of queries from dataset recipients
  • Other duties as assigned
  • The physical demands are representative of those an employee encounters while performing the essential functions of this job
Qualifications:

Education:

  • BA/BS degree in a technical, business or scientific discipline or equivalent in education and work experience

Experience:

  • Minimum 2-4 years of experience in data management for clinical trials, preferably in a Clinical Research Organization (CRO), pharmaceutical or biotech environment
  • Data analysis experience, particularly definition and specification of data structures, database design concepts and data output options
  • Experience using clinical data management systems and tools, such as SAS (Statistical Analysis System)
  • Demonstrable experience in effective verbal and written communications and interaction with internal and external customers
  • Experience in application of knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, Standard Operating Procedures and customer expectations

Skills:

  • Thorough understanding of clinical data management processes through all phases of the clinical trial life cycle
  • Ability to maintain a high degree of confidentiality with clinical data and customer proprietary data
  • Attention to detail and data
  • Good organization, analytical and problem-solving skills
  • Customer management skills
  • Ability to assist in forecasting project resourcing
  • Ability to identify potential out of scope activities to project and DM management
  • Strong command of English language and grammar
  • Proficient in use of computer systems, including Microsoft Office applications such as Excel, Word, PowerPoint, Project, Visio
  • Familiarity with clinical data management systems and tools such as SAS (Statistical Analysis System)
  • Familiarity with applicable regulatory guidance and rules, e.g., 21 CFR Part 11, FDA Guidance

BioTelemetry Research is an Equal Opportunity Employer.

*CB

Company:
Cardiocore Biotelemetry Research

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