What are the responsibilities and job description for the Clinical Data Manager position at Katalyst CRO?
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
- 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.