Leads the clinical data management team at EDETEK, overseeing project management documentation, clinical data management activities, and system implementations for EDETEK's CONFORM eClinical platform, including writing design specifications for forms and reports and facilitating testing of system implementations. Responsibilities include hands-on involvement in data management operations while also overseeing projects to ensure quality, timely delivery, and ongoing client satisfaction; identifying client needs and developing solutions using expertise, operational capabilities, and technologies; and communicating with clients and internal teams. Must thoroughly understand requirements for Good Clinical Data Management services and documentation, participate in start-up or wrap-up of in-house and client-specific data management projects, have an understanding of relevant therapeutic indications, study hypotheses, and trial design, and possess a solid understanding of database design and structure. Essential functions include supporting internal clinical data management initiatives, completing traditional and assigned data management operations, contributing to project success by communicating with clients about requirements and issues, enforcing standard operation procedures, and monitoring project progress and timelines. Also assists in developing and maintaining systems used for project infrastructure, works with Clinical Data Specialists to execute Data Management Plans, leads communication with clients/sponsors to deliver contracted clinical data management services and clinical data with high quality and integrity, ensures filing of all required documentation per EDETEK and project requirements, leads Use Acceptance Testing (UAT) on new software, selects and interviews clinical data manager candidates, and trains and guides junior team members. Required skills include effective communication in English in person, by phone, and in writing; ability to lead functional meetings; strong attention to detail and accuracy; excellent organizational skills; demonstrated ability to manage multiple projects; ability to work collaboratively in diverse organization structures; ability to work independently, take initiative, and complete tasks to deadlines; ability to work in a team-oriented, collaborative environment; ability to work positively in a continually changing environment; ability to prioritize and execute tasks in a high-pressure environment; and advanced computer skills with practical knowledge of MS Office and potentially project management software. Qualifications include a Bachelor's degree or equivalent combination of education/training/experience; a degree in a scientific, medical, or technological discipline preferred; a minimum of 2 years of clinical trial or clinical data management experience or similar industry experience/training required; prior trial responsibility for the entire data management life-cycle desirable; working knowledge of EDC studies and SAS required. The position is based in a corporate office environment with some travel (5%) that may include weekends. Cross-functional interactions are part of the role. Benefits vary by country but remain competitive; a sample of U.S. employee benefits includes choice of comprehensive Medical, Vision, and Dental Insurance plans, paid vacation time and sick days, corporate holidays annually, participation in the 401K Plan, comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc., and Health Advocate and Employee Assistance Program. This is a remote position open to candidates based in the United States. EDETEK is an equal opportunity employer that does not unlawfully discriminate on the basis of race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status, or any other status protected by applicable law, across all terms, conditions, and privileges of employment including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Reasonable accommodations for qualified individuals with disabilities are provided to the extent required by law.

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