Katalyst CRO ยท 2 months ago
Associate Clinical Data Manager
Boulder, CO
Contract
Onsite
New Grad, Entry LevelKatalyst CRO is seeking an Associate Clinical Data Manager to assist in the development, testing, and validation of Electronic Data Capture systems and Case Report Forms. The role involves reviewing clinical data for accuracy, maintaining study documentation, and ensuring compliance with regulatory standards.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Assist in the development, testing, and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs)
Support database setup activities including edit check specifications and user acceptance testing (UAT)
Review incoming clinical data for completeness, consistency, and accuracy
Generate, track, and resolve data queries in collaboration with clinical sites
Maintain study documentation and data management files
Participate in cross-functional study team meetings and data review discussions
Support Serious Adverse Event (SAE) reconciliation and external data reconciliation (e.g., labs, central imaging)
Ensure data management activities follow SOPs, study protocols, and regulatory standards (e.g., ICH-GCP, CDISC)
Qualification
Required
Bachelor's degree in a life science, health science, pharmacy, public health, or related field
Strong attention to detail, organizational, and time management skills
Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint)
Effective written and verbal communication skills
Ability to learn and apply technical systems and software (EDC, CTMS, etc.)
Familiarity with clinical trial processes and Good Clinical Practice (GCP)
Preferred
Experience with EDC systems (e.g., Medidata Rave, Veeva Vault, Medrio) 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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