CDISC Specialist

Location
Rockville, MD
Posted
Feb 21, 2018
Closes
Feb 22, 2018
Function
Other
Industry
Science
Hours
Full Time

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 is seeking a CDISC Specialist with expertise in CDISC Study Data Tabulation Model standards to conduct SDTM mapping, review, and verification of conformance with current CDISC guidelines.

Primary Responsibilities

    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 Maintain and coordinate CDISC standards efforts, ensure maximum reuse of applied standards, involvement in ongoing process improvement efforts and working with teams to provide technical and process guidance Stay current with the evolution of all CDISC standards and be involved in creation and maintenance of process documentation

Requirements

    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 Good Clinical Data Management Practices 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.

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Emmes is proud to be an Equal Opportunity Employer. EOE/M/F/D/V

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