Title Senior Manager, Data Operations
Term: 1 year, potential to extend
Location: Woodcliff Lake NJ – remote until Covid protocols lifted
- 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
- 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.
- 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