Director, Clinical Data Management

Essential Functions: Support the development of CDM Global Standard Operating Procedures (GSOPs)Prepare and defend study specific fee estimates to clients, present CDM capabilities to clients, and communicate project progress, staffing and resource allocation to Senior Director, Data ManagementPlan and execute a resource plan that supports the business; identify technology needs or other gaps; identify and communicate risks to the business and develop solution-oriented approaches to address or mitigate risk; trouble-shoot responsibility by resolving critical issues that impact optimal functioning of the teamProvide direction of activities of Clinical Data Management (CDM) team members regarding completion of project deliverables to ensure they are on schedule according to quality standards, requirements, and project budget from study start-up through archivalProvide direct supervision, guidance, and mentoring to CDM staff while encouraging independence and refining skills of staffProvide effective and timely feedback to management for performance reviews of project team members on an ongoing basisMaintain open communication with internal and external customers by contacting sponsor counterpart on agreed-upon schedule, responding to correspondence promptly and within agreed upon timeframes, and choosing method of communication based on urgency and type of information including governance calls with SponsorsEvaluate team requests by considering factors such as efficiency, quality, budget, resources, and customer relations before committing to an action; seek out existing knowledge prior to developing new methods Competencies: Excellent verbal and written communication skillsKnowledge of Data Management systems including Medidata Rave, OmniComm TrialMaster, and IBM Clinical DevelopmentKnowledge of regional regulations relative to clinical trial conduct, as well as ICH E6 Good Clinical PracticeBase background / knowledge regarding medical terminology and drug nomenclatureAbility to work independently and be self-motivatedBase background / knowledge of the drug development and clinical research processDemonstrated ability to lead project teams Required Education/Experience: BA/BS in Life Sciences with at least 12 years of experience in CDM or Master’s degree with at least 10 years of experienceExperience with EDC systems including Medidata Rave and OmniComm TrialMasterAt least 8 years direct line management experience