Project Standards Manager - NJ in Berkeley Heights, NJ at Apex Life Sciences

Date Posted: 5/5/2018

Job Snapshot

Job Description


Description:

  • The Project Standards Manager within the Clinical Data Standards and Integration (CDSI) group will manage the activities associated with the consistent implementation of clinical data standards for projects and studies. 

Responsibilities will include, but are not limited to: 

  • Operational Support for Implementation of Data Standards 
  • Primarily will be working with Laboratory related standards. Shares the vision for global standards strategy on Laboratory terminology consistency and quality while maintaining an innovative and flexible mindset to ensure study milestones are met 
  • Maintain and update the Global Standards Lab Mapping Table (GSLMT) 
  • Update the GSLMT with the lab terms that are used in a study DTS (Data transfer specifications) to CDISC terms if not already present in GSLMT 
  • Provide instructions and clarifications to study teams if the external data maps to a particular domain (e.g LB, PF, IS) and help them to provide appropriate TEST and TESTCD as per CDISC rules 
  • Develop and maintain project data standards, considering the needs of individual studies within the project, while following global data standards. Make decisions in conjunction with Global Standards Manager(s) regarding when project data standards can and should deviate from 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. 

Provide input into individual study deliverables with data standards components, including: 

  • CRF design, ensuring consistent CRF standards (including metadata) are used for all studies in a project 
  • CRF Completion Guidelines, to ensure consistency across studies within a project in how and when CRFs are completed
  • Programmed edit checks, to ensure consistency across the studies within a project 
  • Data transfer specifications, to ensure consistency across the project in external data structure to facilitate mapping to the SDTM standard 
  • SDTM mapping specifications and SDTM annotated CRF, to ensure consistent SDTM mapping for studies within a project 
  • Work with standards management systems and software, such as a Metadata Repository, OpenCDISC, and issues tracking systems. 
  • 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 custom validation programs. 
  • Communicate and reinforce content and interpretation of data standards to project and study teams, to ensure consistency in understanding and implementation of standards across a project. 
  • Act as the key point of contact for project specific standards implementation issues. 
  • Provide input into project and study timelines and vendor contractual agreements. 
  • Participate in project and study team meetings as needed, specifically in a supportive capacity. 

Standards Support for Submissions:

  • Provide guidance to Submission Team regarding overall project strategy related to data standards for regulatory filings, including how data are to be submitted, the format in which individual studies are to be submitted, and what version of the coding dictionaries are to be used. 
  • Work with the Submission Team to prepare pre-NDA correspondence on submission datasets. 
  • Provide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements, (e.g., SDTM annotated CRF, define.xml/pdf, Reviewer’s Guide, XPT files). 
  • Act as a consulting resource for study teams regarding the validation of eCRT/define packages. 
  • Represent CDSI group on the submission team. 

Other Key Activities:

  • Assist with development of department or cross-functional processes and best practices. 
  • May coach junior personnel or manage contract staff, as required. 
  • Lead or participate in special projects as assigned. 
  • Propose solutions and share best practices with project and study teams, and within DOP as required. 

Skills/Knowledge Required: 

  • BA/BS in a relevant health science or computer science discipline; minimum experience: 7 years as a programmer, data manager, or standards manager with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience. 
  • At least three or more years of hands on experience in converting lab data to CDISC LB domain 
  • Experience in the management of CDISC Controlled Terminology as it relates to Lab and lab type data collection (e.g. Safety labs, Cell Biology, Microscopy testing) 
  • Good understanding of CDISC Laboratory test, Unit terminology 
  • Excellent knowledge of local and central lab processes 
  • Solid understanding of CDISC rules for naming laboratory test codes, test names and units 
  • Strong working knowledge of the Study Data Tabulation Model and the creation of data mapping specifications and annotated CRFs. Knowledge of requirements of define.xml. 
  • Strong project management and negotiation skills. 
  • Ability to work effectively with minimal supervision in a cross-functional team environment, across 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 data validation. 
  • Good communication skills; ability to work 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 is preferred.

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