Manager, Clinical Data Management - (Job Number: 0715365)

Manager, Clinical Data Management - (Job Number: 0715365) DescriptionResponsibilities: The Clinical Data Manager is responsible for working as part of Clinical Affairs to design, conduct, monitor and report on clinical studies. Ensuring the development, validation, management, and maintenance of the clinical database according to Good Clinical Practice standards. Defining data management processes and standardization, and provide leadership, direction and development opportunities to the clinical data management staff. Driving database design within the Clinical Affairs department, serve as an escalation point of troubleshooting and resolving escalated database and site issues with focus on areas of design and database optimization. Strong leadership skills and ability to deal with people on different levels is essential. A thorough understanding of clinical trial methodology and experience to manage a data management group. Provide leadership to the team in electronic data capture and any other emerging technologies in Data Management. Complete training in area of responsibility and assure that direct reports are trained in area of responsibility within allowed time period. Training is required for changes in existing policies & procedures, for new assignments and for implementation of new policies and procedures. Complete required periodic re-training and assure that required periodic re-training takes place for direct reports in areas of safety and environmental. Coordinate and manage all data management activities: review of Case Report Forms, database set-up and design, management of all external data sources, Clintrial and SQL programming, data entry and quality assurance for clinical study monitoring support and preparation of locked study database. Coordinate with Information and data management staff to provide and manage all Clintrial/Oracle systems administration services, including support needed to conduct clinical studies with remote data entry. Development of Biosense Webster data management departmental Standard Operation Procedures, Clinical Protocols ( as needed), Work Instructions and guidelines. Monitor and assure data management staff adherence to all departmental standard operation procedures. Perform metrics on data management processes and guidelines to evaluate efficiency, accuracy and speed in providing clinical study monitoring support and locked database for study reporting. Interface with other managers in Clinical Affairs to provide clinical data and reports that are necessary for the conduct and analyses of clinical research. Interact with managers in other departments, or other Johnson and Johnson divisions regarding data management capabilities. Provide technical expertise in the submission of electronic data, including Oracle and SAS database, electronic signatures, electronic Investigational Device Exemptions and documents needing to be electronically transmitted and archived. Ensure all clinical data management documents, including CRFs and departmental GCPs and Wis are correctly documented, stored and archived. Lead, coordinate, facilitate and manage Clinical Data Management. Prepare budget requirements. Prepare and deliver performance and developmental reviews. Recruit and manage Clinical Data Management associates. Provide training and career development for Clinical Data Management associates. Other responsibilities may be assigned and not all responsibilities listed may be assigned. Experience in database design, either in Clinitrial, Oracle, or SAS. Familiar with SAS Database structures, remote data entry technology, UNIX, network applications, and PDF formats. Overnight travel may be required 10-20%. A minimum of a Bachelor's degree in related scientific/technical discipline required. Masters Degree preferred. A minimum of 8 years in data management, system administration or data analysis. A minimum of 4 years in medical device or pharmaceutical industry is preferred. Knowledge of regulatory requirements (21 CFR part 11), required. Experience with tolls such as Oracle Clinical & SAS is required. A maximum of 20% travel is required. Apply Now