Katalyst CRO · 2 months ago
Clinical Data Manager
Cambridge, MA
Contract
Onsite
Senior Level
7+ years expKatalyst CRO is a company focused on clinical research, and they are seeking a Clinical Data Manager to support the design and validation of clinical trial databases. The role involves overseeing data cleaning and ensuring compliance with industry standards while collaborating with various stakeholders to deliver high-quality datasets for regulatory submissions.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Support the design, development, and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level
Oversee data cleaning, query resolution, and delivery of high-quality datasets to support trial milestones and regulatory submissions
Collaborate with external data management vendors to ensure timely and high-quality deliverables, track performance against project timelines and quality standards
Participate in the preparation, review, and validation of submission-ready datasets for regulatory filings (e.g., NDA, BLA, MAA)
Ensure compliance with industry standards and regulations (GCP, FDA, EMA) and assist in audit and inspection readiness
Coordinate with internal stakeholders including Clinical Operations, Biostatistics, Regulatory Affairs, and IT to ensure smooth data integration and reporting
Contribute to the implementation and optimization of clinical data systems and tools (e.g., EDC, data review platforms)
Qualification
Required
Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related field
7+ years of experience in clinical data management within the biotech, pharmaceutical, or CRO industry
Experience managing study-level data management activities and working with external vendors
Familiarity with clinical data systems (e.g., Medidata RAVE, Oracle Clinical, Veeva) and industry data standards (e.g., CDISC, SDTM)
Strong problem-solving, organizational, and communication skills
Preferred
Demonstrated experience supporting regulatory submissions is a plus
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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