Katalyst CRO ยท 2 months ago
Clinical Data Manager
Atlanta, GA
Contract
Onsite
Senior Level
7+ years expKatalyst CRO is a dynamic organization seeking a Clinical Data Manager to lead clinical data management activities for pivotal trials. The role involves collaborating with cross-functional teams to ensure high-quality data deliverables and overseeing complex multi-study data processes while ensuring compliance with regulatory standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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