Clinical Data manager remote prashanth at Esr healthcare New York, NY

Title Clinical Data Manager - ESR Healthcare Location REMOTE (New York, NY) Contract 6 months with possible renewal (Full‑Time) Experience 12+ Years Responsibilities Provide data management expertise and support to internal project teams, clients, and Clinical Research Organizations (CROs) including study startup documents, data cleaning, DCF/query tracking, database QC, compilation, and maintenance of data management binders and/or files, and SAE/AE reconciliation. Plan, perform, and oversee development of specifications for eCRFs/CRFs, edit checks, electronic data handling, manual review and execution of User Acceptance Testing. Conduct and orchestrate scheduled cross‑functional data reviews, identify issues and track through resolution. Participate in innovation and implementation of new technologies resulting in data management process improvements. Ensure adherence to quality control procedures for data management activities. Write and update Standard Operating Procedures (SOPs) and training guidelines for data management activities. Facilitate and oversee internal study team, client, and CRO meetings. Actively review and provide feedback on study data quality, including providing data management metrics, reviewing project statements of work, and reporting out‑of‑scope activities to the Director. Manage and monitor timelines, ensuring resources are available to meet them. Identify inconsistencies and inefficiencies in data management processes and recommend solutions. Assist in preparation of proposals and budgets for new projects and manage budgets for ongoing projects. Direct and manage team members in daily activities, including training, resource assignment, adherence to timelines, and conducting annual performance reviews. Qualifications 12 years of data management experience, or a B.S./B.A. in a science or technical discipline with 8 years of data management experience, or an MS degree with 6 years of data management experience; minimum 4 years in the Pharmaceutical/Biotechnology industry or CRO environment, and a high degree of proficiency and autonomy in managerial responsibilities. Minimum 4+ years of direct line management experience, managing 3–4 direct reports. 6 years of experience supervising Clinical Data Managers and/or related team activities. Ability to program in SQL or SAS (desirable but not required). Experience with various data collection and Electronic Data Capture (EDC) systems and related tools and processes. Excellent oral and written communication skills. Ability to work in a collaborative and multi‑disciplinary environment. Good knowledge of FDA, EMA, ICH guidelines, and Good Clinical Practice (GCP) regulation concerning data handling and processing. Additional Details Employment Type: Full‑Time. #J-18808-Ljbffr Esr healthcare