Job Summary: We are currently seeking a Associate Director, Data Management in our Edison, New Jersey location . This position serves as the Lead Data Manager responsible for the assurance of overall database consistency across all studies for multiple projects as assigned; serves as an internal consultant for Data Management to Senior Management, external vendors, and strategic partners; provide coaching, mentoring and performance management for all direct reports (when applicable) and advises others on a full range of related tasks and data management projects. Responsibilities: In this position, you will represent Data Management on global and regional project teams to guide teams towards adoption and implementation of established standards and processes; and identifies areas where new standards are needed. Effectively manages assigned projects by adhering to established timelines and deliverables. Reviews all required Data Management documentation for projects, in cooperation with all participating Data Management operating units and personnel. Interfaces regularly with staff in other departments and with external vendors (CROs) to resolve issues and to build efficiencies. Regularly serves as the Daiichi Sankyo Pharma Development spokesperson on range of therapeutic area and data management project issues. Leads global and regional activities related to regulatory submissions for assigned projects (when applicable). Evaluates candidate CROs and external vendors as to their ability to adhere to Daiichi Sankyo SOPs and quality standards prior to finalization of any outsourcing contracts; ensures that all project related outsourcing agreements are comprehensive and complete, as they pertain to Data Management’s activities for these projects. Assists in the development of quality objectives for each project, with input from Data Management units and supported business stakeholders; reviews any study-specific quality objectives and ensures these are reflected in the study Data Management Plans. Serves as a mentor in the department for Senior Project Data Managers, Project Data Managers and contractors where applicable; serves as a department trainer for processes, i.e. GSOPs, GSOIs, regional SOPs, SOIs, work flow, as requested. Establishes project level data management standards (e.g., CDISC) in order to ensure consistency across all studies and to facilitate the global integration of individual study data. Provides input into the compilation of global project databases, including adherence of study data structure to project and corporate standards. Responsible for advising corporate Senior Management on long-range strategic planning. Responsible for liaising and communicating with, and responding to the FDA, our alliance partners, and CROs as requested and required on study related issues as they impact projects. Leads global and regional initiatives to enhance existing processes and procedure and/or develops new processes and procedures to improve data management efficiency and productivity. Provide coaching, mentoring and performance management to all direct reports (when applicable). Education/Experience Masters Degree; Bachelors degree/Registered Nurse in life sciences 7 to 9 years (MS) pharmaceutical experience, including data management and clinical trials. 10 to 12 years (BS/RN) pharmaceutical experience, including data management and clinical trials. 3-5 years supervisory experience. Project management experience. Oral and written communication skills; problem solving skills. Organizational skills; initiative; and flexibility. Project management experience; 6+ years team leadership experience. Advanced office computer proficiency. Full knowledge of GCP/FDA guidelines, SOPs, medical terminology, regulatory submissions and experience applying them to all relevant therapeutic areas. Full knowledge of clinical data flow and research design. Experience leading process improvement initiatives to increase overall efficiency and productivity. CRO management experience including day to day operations as well as extensive knowledge of CRO audits. Exhibits strong leadership, communication (written and oral), and problem solving abilities. Flexibility and innovation Works well in a cross functional team environment Demonstrates Daiichi Sankyo Pharma Development core competencies at the individual contributor level; exhibits Daiichi Sankyo values. Valued performer or above for at least two review cycles; management recommendation (internal candidates). Must be willing to travel 10% of the time.
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Research and Development