Katalyst CRO ยท 2 months ago
Clinical Data Manager
Princeton, NJ
Contract
Onsite
Mid, Senior LevelKatalyst CRO is seeking a highly motivated and detail-oriented Clinical Data Manager to join their dynamic clinical research team. In this pivotal role, you will oversee the collection, management, and validation of clinical trial data to ensure accuracy, integrity, and compliance with regulatory standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead the design, development, and implementation of data collection tools and databases aligned with study protocols and CDISC standards
Supervise data management activities across multiple clinical trials, ensuring timely and accurate data entry, validation, and reconciliation
Review source documents and case report forms (CRFs) meticulously for completeness, consistency, and compliance with regulatory requirements such as FDA regulations and ICH GCP guidelines
Collaborate closely with clinical research teams to monitor patient data collection processes, including vital signs, blood sampling, and patient monitoring activities
Oversee the review of laboratory reports, EMR systems integration, and other clinical documentation to maintain high-quality data standards
Ensure adherence to HIPAA regulations and maintain confidentiality of patient information throughout all data management procedures
Utilize statistical software tools for data analysis support and prepare datasets for statistical review and reporting
Manage documentation workflows, including audit trails, protocol amendments, and regulatory submissions to ensure compliance with FDA regulations and ICH GCP standards
Provide supervision and mentorship to junior staff or contract personnel involved in data management activities
Support clinical laboratory activities by understanding blood sampling procedures, phlebotomy protocols, and analysis skills necessary for accurate data interpretation
Qualification
Required
Proven supervising experience in clinical trial environments with a strong understanding of clinical trials management processes
Extensive knowledge of medical terminology, clinical research methodologies, and regulatory frameworks such as FDA regulations and ICH GCP guidelines
Proficiency in data collection methods using EMR systems, electronic data capture (EDC) platforms, and CDISC standards for data formatting
Strong documentation review skills with attention to detail in source documents, case report forms (CRFs), lab reports, and other clinical records
Experience monitoring patient safety parameters including vital signs and blood sampling procedures within clinical trials
Familiarity with statistical software packages used in clinical research for data analysis purposes
Knowledge of clinical laboratory procedures related to blood sampling, phlebotomy techniques, and blood sample handling
Ability to manage compliance requirements related to HIPAA privacy rules while handling sensitive health information
Excellent analysis skills for identifying discrepancies or inconsistencies in complex datasets; capable of troubleshooting issues proactively
Understanding of research protocols involving clinical development phases from early-phase studies through late-stage trials
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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