We are seeking a leader to head the DM team in overseeing several ongoing trials, starting-up new trials and providing DM vendor oversight activities across the development programs. The incumbent will work closely with the head of Biometrics in identifying project DM demands and resource needs. Provides hands-on support to project teams by leading data management efforts, and coordinating with external vendors, data managers, and other business functions to ensure timely and quality delivery of data management deliverables for clinical projects. Contributes to the overall efficiency and best practice running of the Biometrics group, demonstrating the ability to work efficiently and to a high standard within a cross-functional team environment. Strong technical skills and experiences supporting regulatory submissions are required.
• Provide strategic input to and leadership of data management contributions across all clinical development projects.
• Provide oversight of multiple programs, including timelines, resources and budgets. Ensure that budgets and timelines are adhered to (eg, DB go live, data base locks, etc.).
• Manage and provide oversight of CROs and third-party providers to ensure successful clinical trial implementation and execution.
• Ensure data quality by reviewing, query writing, identifying protocol deviations, as well as coding.
• Lead or contribute to the development and review of case report forms, database specifications, and validation plans and supportive documentations, including UAT.
• Develop and maintain data management-related SOPs, work practice documents, technical standards, and data specification documents.
• Identify and lead the application of data management approaches to support all aspects of the clinical development process. Leverage tools to collect and manage data to enable decision making. Identify the need for and lead the development and maintenance of applications used for data collection and management.
• Manage data managers and contribute to the professional development of Biometrics personnel by conducting trainings and coaching.
• Bachelor degree in life science, pharmacy or related discipline. Masters preferred.
• Minimum of 12 years of experience in Data Management. Lead DM experience is required.
• Strong understanding of data management and clinical related issues along with an ability to demonstrate significant leadership of technical activities (eg, database development, cross-system integration, etc.) in a clinical pharmaceutical/CRO environment.
• Experience in all study phases, from study start-up to submission. Registry experience a plus.
• Demonstrated experience with managing vendors or direct reports and success at leading teams.
• Knowledge of drug development process.
• Understanding of ICH Guidelines and GCP Requirements as they pertain to data management.
• Well-versed in different EDC Systems.
• Ability to develop and maintain timelines.
• Experience in managing several programs.
• Excellent communication skills and interpersonal skills.
• Travel 10-20%