Katalyst CRO · 1 month ago
Clinical Data Manager
Princeton, NJ
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is a clinical research organization specializing in data management for clinical trials. They are seeking a Clinical Data Manager to lead clinical data management activities for multiple complex studies, ensuring compliance with regulatory requirements and improving data quality throughout the trial process.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead clinical data management activities for multiple complex studies, from study startup to database lock and final reporting
Develop and manage data management timelines for multiple projects, ensuring all milestones are met according to project plans
Design, build, and oversee the implementation and management of clinical trial databases using Electronic Data Capture (EDC) systems (e.g., Medidata, Medrio, or similar)
Develop and oversee maintenance all data management documentation for all clinical studies
Ensure clinical data is captured accurately and efficiently, incorporating appropriate data validation checks and edit checks
Oversee data validation processes, including data cleaning, discrepancy management, and query resolution
Ensure data accuracy, completeness, and compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (CDISC, SDTM, WHO Drug, MedDRA)
Perform data review and provide feedback to study teams to improve data quality and resolve issues early in the trial process
Ensure clinical data management activities are compliant with regulatory requirements (FDA, EMA), ICH GCP guidelines, and other relevant regulations
Prepare and contribute to regulatory submissions, including clinical study reports, and support data auditing processes
Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and execution
Serve as the primary point of contact for data management vendors and external partners, ensuring effective communication and timely issue resolution
Manage independent vendor and CRO biostatistical services performance and oversee compliance with contracts while ensuring budgetary efficiency
Develop, implement, and continuously improve clinical data management processes and systems
Lead initiatives to enhance the efficiency and effectiveness of clinical data management, including the evaluation of new tools, software, and methodologies
Qualification
Required
Bachelor's or Master's degree in life sciences, health informatics, computer science, or related field
Strong understanding of data structure and data systems
Minimum of 5+ years of experience in clinical data management
Proven experience managing data across multiple phases of clinical trials
Proficiency with EDC systems (e.g., Medidata Rave, Medrio)
Strong understanding of CDISC standards (CDASH, SDTM, ADaM) as well as WHO Drug and MedDRA coding
Thorough understanding of clinical trial processes, regulatory requirements (e.g., FDA, EMA), and GCP standards
Strong leadership and project management skills, with the ability to manage multiple priorities in a fast-paced environment
Excellent communication, problem-solving, and decision-making skills
Ability to work collaboratively with cross-functional teams and manage relationships with external vendors
Preferred
Advanced degree preferred
Familiarity with data reporting tools is a plus
Certified Clinical Data Manager (CCDM) or similar certification is preferred
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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