Responsibilities: This position is responsible for data management activities, including developing data management plans, validating/testing databases, defining specifications to review data (manual, automatic (EDC edit checks), and SAS validations), and reviewing/tracking clinical trial data to ensure the completeness, accuracy, and consistency of the data collected during clinical trials Study Specific Activities. Coordinate and complete data management activities to meet project timelines and communicate status to clinical project managers. Develop study specific data management plans and case report form (CRF) completion guidelines. Review and approve documents associated with data collection: CRFs, edit checks, data handling conventions, and data entry instructions. Review and finalize clinical study database validation plans, lead the database validation team, and ensure all documentation is completed prior to GO-LIVE. Complete data verification process (i.e., issue data clarification forms (DCFs) for paper CRFs or issue queries for EDC). Review completed DCFs and/or queries to ensure data discrepancies are resolved in the database. Prepare electronic data transfer protocols and coordinate data transfers (imports and exports) with third party vendors and consultants and Project Biostatisticians. Lead database cleaning and lock activities, coordinating data transfer reconciliation, serious adverse event reconciliation, and database audits with QA or data quality reviews with another Clinical Data Manager. Ensure all study specific documentation is filed appropriately in the study-specific Trial Master File. Manage and prioritize data management activities to meet project schedules. Report on required data management metrics to ensure efficient review of data. Develop data management resource forecasting and tracking model to assist with project planning and support. Optimize database development and validation processes to improve departmental efficiency. Train and mentor Clinical Data Associate(s) to develop clinical data review and other technical data management skills. Requirements: Bachelor's degree in a scientific discipline, at least 3 years of clinical data management experience in the pharmaceutical/biotechnology industry. More experience will be required for a senior level CDM candidate. You must be highly detail-oriented while still maintaining work efficiency, be able to prioritize activities and multi-task across various projects that will be at different study stages. We prefer you to have MedDRA and WHO Drug coding proficiency. Katalyst Healthcares and Life Sciences
...Solutions is working with a school district who is looking for an SLP to work with their team. This full-time position will be... ...021-2022 school year. This position can be 100% remote through teletherapy. Requirements: Must hold an active DE license or will need...
...leaders, and partners we design practical solutions that solve real problems for major government and business organizations. The Proposal Writer will be responsible for developing Tagup responses to requests for proposals (RFPs) from potential and existing customers by...
...Job ID: 508352 Oldcastle APG, a CRH Company, is the leading provider of outdoor living solutions in North America with an award-winning portfolio that enables customers to Live Well Outside. Inspiring endless possibilities with enduring performance, its collection...
...Job Description Job Description We are seeking a Small Engine Mechanic/Technician for immediate hire in Port Carling, Ontario. Located... .... Relocation assistance is available. This is a fleet repair position maintaining lawn and turf equipment. If you are looking...
...talents. Our customers include top household tech brands, and our supporters include well-known industry leaders and top financial... ...What We're Looking For Minimum of 8 years experience in software development (Java, PHP, Python), with a focus on building scalable...