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

Date Posted: 2/1/2018

Job Snapshot

Job Description


We are looking for a Senior Project Standards Manager to join our Global Pharmaceutical Company located in Berkeley Heights, NJ. The ideal candidate will have BA/BS in a relevant health science or computer science discipline, 10 years as a clinical programmer, data manager, or data standards manager with progressive responsibilities in a pharmaceutical/CRO setting, or comparable relevant experience. A medical background is a plus. This is a contract position with the possibility to convert to permanent. 

Description:

  • The Senior 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: 

  1. Operational Support for Implementation of Data Standards 
    • Independently 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 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. 
      • 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. 
      • 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. 
      • Coach CROs and vendors on data standards and related processes. 
      • Provide standards support to multi-project development programs, including early strategic assessments. 
  2. Standards Support for Submissions 
    • Provide leadership and 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 regulatory correspondence regarding submission standards. 
    • 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.
    • Participate in submission team meetings. 
  3. Other Key Activities 
    • Provide project oversight and coaching to more junior personnel, or manage contract staff. 
    • Lead development of department or cross-functional processes and best practices, including CDSI SOPs, Working Procedures, and Guidance Documents. 
    • Lead or participate in strategic initiatives, special projects, and working groups. 
    • Participate as a member in Clinical Data Standards Governance Organization (CDSGO). 
    • Independently develop and propose innovative solutions, and share best practices with project and study teams, and within department as required. 
    • Identify root cause of problems and implement creative solutions. 
    • Independently identify and propose process improvements while maintaining a strategic focus. 
    • Lead or participate in the identification, review, and evaluation of new technologies related to data standards. 
    • Ensure effective communication and collaboration between CDSI and other functional groups impacted by clinical data standards. 

Skills/Knowledge Required: 

  • BA/BS in a relevant health science or computer science discipline; minimum experience: 10 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. 
  • Emphasis is on someone with strong communication skills. 
  • 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. 
  • Strong project management and negotiation skills. 
  • Ability to work effectively on an independent basis 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 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 and lead 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.

For immediate consideration, please email resumes to mbingham@apexlifesciences.com