CDISC Data Manager
The EMMES Corporation, organized in 1977, is a privately owned Contract Research Organization (CRO) located in Rockville, Maryland. Emmes is dedicated to providing statistical and epidemiological expertise, computer systems development, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in clinical and biomedical research.
Emmes serves as the Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases (CRID) for more than 100 protocols sponsored by the National Institute of Allergy and Infectious Diseases’ (NIAID) Division of Microbiology and Infectious Diseases (DMID). Under the CRID contract, Emmes provides statistical, data management, and operational support for studies evaluating the safety, immunogenicity, and efficacy of vaccines and therapeutics against infectious diseases. These studies address critical public health needs to respond to emerging and re-emerging infectious diseases and potential agents of bioterrorism.
The Emmes CRID project is seeking a Data Manager with expertise in CDISC Study Data Tabulation Model standards to conduct SDTM mapping, review, and verification of conformance with current CDISC guidelines.
Review protocols for CDISC conformance
Develop and review Case Report Forms and eCRFs with CDISC CDASH and SDTM conformant elements
Utilize proprietary Emmes software and mapping tools to annotate eCRFs and create data elements for SDTM output
Review and verify SDTM data elements, SDTM annotations, and SDTM datasets and their conformance with the SDTM Implementation Guide, project standards, and the study protocol
Create and review submission ready SDTM datasets, define.xml, and supporting documentation, as appropriate
Provide CDISC training and serve as a subject matter support to project staff
Perform other data management duties, including development and implementation of data quality checks, issuing queries, generating and QCing data reports and deliverables to the sponsor, as required
Bachelor’s degree or Master’s degree with 2 years related experience, and demonstrated working knowledge of scientific principles appropriate to the position
Excellent oral and written communication skills
Prior experience with CDISC SDTM standards and application of standards to clinical trial data
Documented training in CDISC SDTM, strongly preferred
Prior experience with SQL and other database programming is preferred
Strong interpersonal skills and ability to work with staff at all levels with sensitivity and tact
Demonstrated ability to foster concepts of teamwork, research integrity, ethical conduct, and personal responsibility
Ability to self-direct and work independently and in a complex team environment
Knowledge of clinical research including the critical elements for the development and execution of clinical trials or research studies
Strong skills in prioritization, organization, problem solving, decision-making, time management, mentoring, and planning
Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs. CONNECT WITH US!! Follow us on Twitter - @EMMESCorp Find us on LinkedIn - The EMMES Corporation
Emmes is proud to be an Equal Opportunity Employer. EOE/M/F/D/V