Participate or may oversee EDC design requirements development. Manages development of and updates of global library objects as appropriate according to best practices and new standards.Ensures accuracy and timelines for the 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 or oversee user and site administration to include site set up and assignment of roles, permissions and eLearning requirements.Ensure completeness of study build deliverables prior to release.Ensure accuracy or perform peer review for the studies built by other programmers.Ensure Maintenance of 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.Oversee Coding, testing and implementing custom or vendor supplied systems software.Design or oversee applications to best meet business goals and functional requirements.Devise methods to explore and implement new functionality to existing systems.Researching emerging technologies to determine what can increase an organization s efficiency and effectiveness.Develop and/or oversee coordination of 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.Train or oversee training the systems end users.Provide ideas as related to DM efficiencies.Work closely with DM and Data Operations Direct reports on work related to ECCE program etc.Line Manager of Direct Repots and Contractors, in the area of development, defining objectives, and performance.
Requirements & Experience : Master s degree in Computer Science or related fields required with at least 15 years of life sciences industry experience.Minimum of 10 years of experience in Electronic Data Capture (EDC) systems and Interactive Response Technology (IRT) systems.Expertise in Data Visualization tools like Spotfire, Review, Tableau, etc.Expertise with FDA regulations, handling Audits, System Validation & QC methodologies. Must be able to oversee systems development and clinical submission data.Expertise in CDISC standard data sets, like SDTM is preferred. Oversee the quality and efficiencies of work by an offsite group performing SDTM programming.Experience with health authority inspection is desirable.5 years or above of line management experience.
About Us : Since 2004, Orbis Clinical has been a leading global recruiting partner to the life sciences industry, helping to drive the success of our clients, consultants and employees. Our clients range from venture-backed start-ups to Fortune 500 firms, and we match your skills, experience and career aspirations to find you just the right fit. We have the unique opportunity to make a meaningful impact on the future of healthcare by finding the best minds in life sciences (like yours!), and pairing them with both emerging and established companies who are innovating treatments with a variety of organizations, including: Biotech/Pharmaceutical Medical Device Clinical Research Organizations (CROs) Hospitals, Universities, and Research Sites Government and Academic Institutions
Why Work With Us : Individual dedicated recruiter Deep networks to connect you with the most up-and-coming, recognized positions in your field Life Sciences experts with consultative approach Exclusive searches with direct connections to decision makers
PandoLogic. Category: Logistics, Keywords: Operations Director
Tagged as: management
To apply, please visit the following URL:https://www.jobs2careers.com/click.php?jid=4110ad6a079d61eeb0748a0c9&ri=94451c581c3b447aa34191019b733b48&job_loc=Nutley%2CNJ&q&spl=wk0cY8SbzMvyRUJR%3AtcUCllMoyA1gPhwAK7Y%2FZw%3D%3D%3AGRHmpFAVT5pQyJhShbxgewy5DjwqJiNnXAltfz4zVA%3D%3D&encrypt=0&l=New+York%2C+NY→