RESPONSIBILITIES Serve as primary point of contact for customer on data management deliverablesManage multiple large studies or program of studies (possibly global)Provide leadership and senior support to DTLs on multiple large global programs of global studiesProvide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertiseLead direct negotiations with customer, e.g., timelines, financial, process, resourcesMeet with Data Operations team members on a regular basis to ensure milestones meet timelines and quality deliverablesIndependently manage DM service delivery with comprehensive DM process and technical expertise in executing projectsServe as the escalation point for unresolved data issuesEnsure appropriate resources are assigned to meet project deliverablesCreate and/or review and sign-off on all data management plan (DMP) documentsManage service performance and provide leadership to identify root causes of issues and implement remedial actionsServe as Subject Matter Expert (SME)Provide leadership and expertise in a specific CDM task or technologyIndependently manage SOW/budgetIndependently bring process improvements and solutions to the CDM team/CDM departmentLead a focus team or global or local best practice teamProvide review and expert opinion in developing, revising, and maintaining core operating procedures and work instructionsREQUIRED KNOWLEDGE, SKILLS AND ABILITIESPrevious experience and proven competence in managing delivery of multiple global trials through full DM life-cycle (i.e. large trials of at least 1000 patients)Demonstrated expert data management skills and advanced knowledge of the data management process (e.g., therapeutic area, extensive knowledge in DM processes, SAE reconciliation, external data vendor reconciliation)Previous experience and proven competence in handling complex customer negotiations and bid defense meetings independentlyKnowledge of Medical Terminology, Pharmacology, Anatomy, and/or PhysiologyKnowledge of operating procedures and work instructions and the ability to apply them in practiceKnowledge of Good Clinical Practices and relevant regulatory guidelinesExcellent communication, interpersonal, customer service, and teamwork skillsExcellent organizational and problem-solving skillsExcellent project management skillsAbility to work independentlyComprehensive understanding of clinical drug development processAbility to establish and maintain effective working relationships with co-workers, managers and customersMINIMUM REQUIRED EDUCATION AND EXPERIENCEBachelor's Degree, or educational equivalent, in health, clinical, biological or mathematical sciences, or related fieldAround 7 years direct Data Management experience, including 5 or more years as a CDM project lead; or equivalent combination of education, training and experience
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