Clinical Data Manager The CDM will be responsible for developing data management plans and quality management plans that will deliver accurate, timely, consistent and quality clinical data. Responsibilities : Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts Serve as the project and client liaison to CROs including management and provision of project specific data management status, cycle time, and productivity metrics Coordinate and participate in the development of the clinical data model and/or database designs and annotate the CRF (eCRF) according to the specifications Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, statistical analysis plans, and CRF (eCRF) completion / monitoring conventions Coordinate the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality Be responsible for advanced planning and risk management for projects (issue escalation, resource management) Oversee the technical performance of the data review project staff at CRO through delivery of quality data, on-time and on-budget Assist with objectives for data review by CRO Maintain technical data management competencies via participation in internal and external training seminars Oversight of CRO staff training and adherence to project-specific, global, standardized data management process Collaborate with CRO on areas for process and efficiency improvement and implement solutions on assigned projects Review literature and research technologies/procedures for improving data management practices for the Company in collaboration with CRO Perform other data management duties such user acceptance testing, data listing reviews, data trend reporting, timeline confirmation for database lock, etc. Education/Qualification: Bachelor’s degree in business, computer science, math, science or a related field 5+ years relevant experience in a CRO, biotechnology or pharmaceutical company Broad knowledge of the drug development process Understanding of global clinical development budgets Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred Knowledge of SAS preferred Knowledge of time and cost estimate development and pricing strategies for data management services, EDC vendor selection, ancillary database transfers Ability to manage multiple projects/priorities Excellent oral and written communication skills #J-18808-Ljbffr Excelsior Executive Search
...experience, mutual respect, embracing our diversity, continuous improvement, ethical behavior, and accountability. A Helicopter Pilot position is available with the City of Fort Worth Police Department Air Support Unit. This position will contribute to the Citys...
...strategies to promote our brand, products, and services across various platforms including Facebook, Instagram, Twitter, LinkedIn, and TikTok. Create engaging and relevant content, including graphics, videos, and written posts, that resonates with our target audience....
...including aggregates, cement, ready-mixed concrete and asphalt. Through a network of operations spanning 28 states, Canada and the Bahamas, dedicated Martin Marietta teams supply the foundational resources upon which our communities thrive. Martin Marietta's Magnesia Specialties...
...Job Description Job Description Kept Companies is the largest self-performing commercial cleaning and maintenance company in the nation. With nine leading brands and over 100 locations nationwide servicing industries including restaurant, solar, retail, transportation...
Job Description Position Responsibilities (including but not limited to): Optimize existing and develop new service catalog offerings and associated flows with a focus on continual improvement and automation. Leverage Flow Designer to further mature the service catalog...