Data Standard Manager / Clinical Programmer
at Pyramid Consulting, Inc

Date Posted: 7/20/2019

Job Description

Immediate need for a Data Standard Manager / Clinical Programmer experience in the Pharmaceutical Industry. This is 12+ Months Contract position with possible extension located in Berkeley Heights, NJ. Please review the job description below:

JOB ID # 19-20933

• Participate in the development and maintenance of global clinical data standards, including operational (eCRF and external) CDISC Study Data Tabulation Model (SDTM), controlled terminology, external standard data mappings (e.g., lab or ECG), and other applicable standards. This could include creation of the metadata and mappings between the standards (operational and SDTM), and documentation of the use of the standard.
• PSM will develop and maintain global data standards, considering the needs of individual studies within the indication, while following Client standards conventions. Make decisions in conjunction with GSM regarding when project data standards can and should deviate from Client global data standards. Data standards will include, but not be limited to, the CDISC Study Data Tabulation Model (SDTM), Controlled Terminology, or other relevant, current industry standards models.
• Participate in relevant study team meetings and provide standards expertise for the following standards components, including:
o CRF design, ensuring consistent CRF standards (including metadata) are used for all studies in a project
o CRF Completion Guidelines, to ensure consistency across studies within a project in how and when CRFs are completed
o Programmed edit checks, to ensure consistency across the studies within a project
o Data transfer specifications, to ensure consistency across the project in external data structure to facilitate mapping to the SDTM standard
o SDTM mapping specifications and SDTM annotated CRF, to ensure consistent SDTM mapping for studies within a project
• Act as an expert on operational data standards, SDTM and/or Analysis Data Model (ADaM) standards, and Clinical Data Interchange Standards Consortium (CDISC) controlled terminology.
• Work with standards management systems and software, such as Metadata Repository, Change Request systems, SDTM validation systems, and issues tracking systems, in the development of systems and processes for creation and maintenance of data standards, including specifications, mappings between standards, and checking adherence to these data standards.
• Coach CROs and vendors on Client data standards and related processes
• Act as a consulting resource for study teams regarding the validation of SDTM domains, which may include output from software tools such as OpenCDISC and Client custom validation programs.
• Communicate and reinforce content and interpretation of Client data standards to project and study teams, to ensure consistency in understanding and implementation of standards across a project.

Skills/Knowledge Required
• BA/BS in a relevant health science or computer science discipline; minimum experience: 5 years as a clinical programmer, data manager, or data standards manager with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience. Medical background is a plus.
• Strong working knowledge of the overall pharmaceutical development process.
• Strong working knowledge of SDTM and the creation of data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml.
• Project management and negotiation skills.
• Ability to work effectively on an independent basis in a cross-functional team environment, across Client departments, and with external vendors
• Computer skills: knowledge of data structures within clinical data management systems, especially electronic data capture systems; understanding of SAS, including ability to use SAS System Viewer and to create basic SAS queries. Experience in programming databases is a plus. Experience with a Metadata Repository or other related standards management system is preferred.
• Experience in CRF design, query resolution, and general data validation.
• Good communication skills, high ability to communicate standards related issues, options, and their impact to project teams and within department.
• Ability to work effectively in a team environment with medical personnel, study managers, project managers, clinical monitors, data managers, programmers, and statisticians
• Experience with regulatory submissions or working with submission teams
• Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data

Our client is a leading Pharmaceutical Organization and we are currently interviewing to fill this and other similar Contract positions. Qualified candidates should apply online for immediate consideration.

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