Fully Remote Contract - Sr. Manager, Clinical Data Management

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Posted 7 days ago United States Salary undisclosed
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Job Description

Title Contract Sr. Manager, Clinical Data Management Location Fully Remote Duration 12+ Month contract About the Company A global Contract Research Organization Benefits Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short termlong term disability. About the role Responsible for timely and high-quality data management deliverables supporting the portfolio. Establish asset and study level strategies and services, including excellence in the application of standards. Your Main Responsibilities Responsible for data management oversight of the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH Google Cloud Platform, local regulations and SOPs), on schedule and on budget Conducts oversight of data management activities performed by Strategic Partners andor other CROs and other 3rd party vendors to meet obligations described in ICH-Google Cloud Platform and business objectives. Activities include from protocol synopsis through database release and submission Contributes to the management of vendor partnerships to maximize effectiveness and maintain budgets. Serves as a clinical data management expert and provides guidance on CDISC standards. Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and for all data related deliverables, especially in support of key decision points and regulatory submissions. Contributes influential leadership in collaboration with other Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality. Provides input to functional governance with strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor andor cross-functional teams. Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics. Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents Oversees the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of the firm. Participates and represents function in formal inspections and audits as requested. Basic Qualifications BSBA required preferably in a health-related, life science area Minimum of 8 years data management andor drug development experience. Proven track record of strong project management skills and experience managing data management activities for large drug development programs Experience with all phases of development and at least 2 therapeutic areas. Ability to handle multiple development programs simultaneously. NDACTD Experience. Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials. Strong working knowledge of (e)CRF design and data management functionsactivities as applied to standards library development and maintenance. Good understanding of CDISC standards, and experience implementing standards. Strong knowledge of clinical study reporting requirements including SAS programming. Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles. Experience in medical coding in the pharmaceuticalbiotechnology industry including knowledge of coding tools. Sthree US is acting as an Employment Business in relation to this vacancy.