Senior Manager, Data Operations

Title Senior Manager, Data Operations

Clinical

Term: 1 year, potential to extend

Location: Woodcliff Lake NJ – remote until Covid protocols lifted

Requirements

  • A highly specialized and technically inclined individual in overseeing Systems development and Submission data.
  • Minimum of 10 years’ experience in Electronic Data Capture (EDC) systems and Interactive Response Technology (IRT) systems.
  • Expertise in Data Visualization tools like Spotfire, JReview, Tableau etc.
  • Master degree in Computer Science or related fields with at least 15 years of industry experience
  • Expertise with FDA regulations, handling Audits, System Validation & QC methodologies

Job Summary

  • Responsible for the Study Build, Validation and Deployment activities of all systems.
  • Quality checks of clinical study as they relate to data collection and cleaning, from study start up through ongoing oversight to completion.
  • Develop essential Procedural documents, Data Review Plans and Data Clean Listings.
  • Perform user acceptance testing and review protocols and develop scripts.
  • Develop and lead training, user acceptance testing and review protocols to ensure consistency.
  • Perform system validations and User Access Management activities.

 

Essential Functions

  • Participate in EDC design requirements development.
  • Support development of and updates of global library objects as appropriate according to best practices and new standards
  • Design/create and validate clinical databases including forms, folders, matrices, data dictionaries/code lists, unit dictionaries, edit checks/rules, derivations, custom functions, standard and custom reports
  • Perform user and site administration to include site set up and assignment of roles, permissions and eLearning requirements
  • Verify completeness of study build deliverables prior to release
  • Perform peer review for the studies built by other programmers
  • Maintain all required Clinical Systems study documentation
  • Provide EDC technical support to facilitate study timelines and deliverables.
  • Provide support for EDC system upgrades, Review of User Requirements, User Acceptance Testing
  • Provide technical assistance and training to technical / non-technical personnel.
  • Coding, testing and implementing custom or vendor supplied systems software.
  • Designing applications to best meet business goals and functional requirements
  • Devising ways to explore and implement new functionality to existing systems
  • Researching emerging technologies to determine what can increase an organization’s efficiency and effectiveness
  • Developing and coordinating comprehensive systems test plans.
  • Documenting all work per IT standards and process including change management.
  • Coordinating all documentation of systems policies and procedures as well as training materials
  • Training the systems’ end users
  • Accepted file types: doc, pdf, txt, docx.