Katalyst CRO · 2 months ago
Sr. Clinical Data Manger
Chicago, IL
Full-time
Onsite
Senior Level
5+ years expKatalyst CRO is a company specializing in clinical research services, and they are seeking a Senior Clinical Data Manager. The role involves overseeing all aspects of clinical trial data management, ensuring data accuracy, compliance, and collaboration with the Clinical Operations team.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Clinical Data Manager will be responsible for all aspects of clinical trial data management from study start up through database lock and study close
This includes the EDC build and user acceptance testing (UAT), study data cleaning and reconciliation, query issue and resolution, and database locks
They will ensure optimized data collection, flow and access across EDC and non-EDC data sources
They are also responsible for accuracy, consistency, completeness and CDISC compliance of all clinical databases
The role will operate as a key member of the Clinical Operations team
Develop and maintain all data management documentation, including case report forms, data management plans, edit check specifications, data review plans and data transfer agreements
Design case report forms (CRFs) for electronic data capture (EDC) systems for data collection
Perform data entry and cleaning activities, including discrepancy management and query resolution
Conduct data validation checks and implement quality control measures to ensure accuracy and completeness
Collaborate with study team members to resolve data-related issues and discrepancies
Generate and review data listings, summaries and reports for data review
Serve as a primary or backup resource for issues about data management
Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations
Contribute to the development and validation of data management software tools
Qualification
Required
BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience
5-7 years of data management experience in the pharmaceutical or biotechnology industries
Strong expertise in project/program management including stakeholder management
Knowledge of industry standards (CDISC, SDTM, CDASH)
In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11
Proven ability to pre-emptively identify data and system issues and mitigate risks to data quality
Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data
Experience in development and implementation of Clinical data management standards and procedures
Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug
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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