Clinical Data Manager

Responsibilities Lead clinical data management activities for pivotal trials in a dynamic environment. Collaborate with cross-functional teams to ensure high-quality data deliverables. Drive vendor management and oversee complex multi-study data processes. Develop and maintain critical data management plans and guidelines. Ensure compliance with regulatory standards and industry best practices. Support NDA submissions and pipeline projects in a strategic role. Work hands-on to set up SOPs and optimize data workflows. Contribute to a collaborative, data-driven startup environment with growth potential. Act as Study Lead for multiple clinical trials, ensuring data integrity and quality. Coordinate with stakeholders to align data management activities with project goals. Oversee database design, validation, and implementation processes. Manage vendor relationships and ensure adherence to timelines and standards. Develop and review study protocols, management plans, and statistical analysis documents. Ensure compliance with GCP, SOPs, and regulatory requirements in data processes. Perform supplemental data reviews and quality checks for clinical trials. Provide strategic input for SOP development and process optimization Requirements: Bachelor of Science (BS) degree with 710 years of clinical data management experience. Extensive knowledge of EDC systems, CDISC standards, and data visualization tools. Proven experience managing NDA submissions and vendor relationships. Strong understanding of database structures and regulatory compliance standards. Hands-on expertise in pipeline projects and SOP development. Ability to work in a fast-paced, detail-oriented, and collaborative environment. Proficiency in managing data quality and integrity across complex trials. Strong interpersonal and organizational skills with a proactive approach.