Rec#CT4497 Location: Swiftwater, PA Duration: Full time Salary up to 120K + possible signing bonus & excellent benefits package

The Clinical Data Manager (DMG) is responsible for managing Clinical Data Management (CDM) activities in accordance with project timelines and operating procedures ensuring compliance with regulations as well as GCPs. Key trial activities for internal projects include planning and approving database design as well as managing clinical data through project life cycle through database clean and lock. For outsourced trials, the DMG provides supervision, monitors deliverable quality and approves major milestones. The DMG is responsible for representing CDM both internally and externally and for analyzing current operating techniques in order to insure optimal usage. The technical/functional environment is the CDM platform, operating through a Clinical Data Management System (CDMS), within the Clinical Operations group of the Clinical department. The DMG reports to the Deputy Director, Clinical Data Managers - North America for appraisal and training and is accountable to Clinical Team Leaders for clinical project issues. The DMG represents CDM on Clinical Teams, works with other CDM staff to ensure consistency of operating practices and works with Clinical Team Leaders and/or Clinical Coordinators to evaluate the necessary CDM resources needed to meet expected project timelines. Monitors project timelines and works with Clinical Operation staff to assist with evaluating the necessary CDM resources needed to meet expected project timelines. Assists with implementation of CDM strategies to meet expected project related goals. Organizes methods to meet timelines and assure quality output. Identifies potential difficulties in reaching project timelines and offers solutions to resolve any difficulties that may deter project goals. Provides guidance and assistance to clinical team members for problem resolution. Ensures all operational aspects needed for CDM are achieved to perform functional tasks, including data capture, encoding, cleaning and database lock. Researches potential improvements to operating procedures for the platform and advancements in CDM. Works with counterparts based at other sites to implement necessary changes and improvement for the platform. Supports and aids in the design of databases for clinical studies performed in-house. Assists with testing of clinical databases to ensure functionality. Performs and documents validation procedures and edits. Provides locked clinical databases (i.e. SAS datasets) for statistical analysis within timelines requested. 4 year degree at an accredited institution with 5 years experience in data management in clinical/medical field Working knowledge of data management software and computing skills required. Salary: $120K MAX w/ sign-on bonus. Relocation fully provided. 15% annual bonus. Excellent benefits immediate available including 401K matching up to 6%.

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