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.
Requirements:
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.
Numbers & Facts
Location
Lake county, IL
Skills
Acceptance Testingunmatched
Bioinformaticsunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Case Report Form (CRF)unmatched
Clinical Dataunmatched
Clinical Data Interchange Standards Consortium (CDISC)unmatched
Clinical Data Managementunmatched
Clinical Information Systemsunmatched
Clinical Practices/Protocolsunmatched
Clinical Trial Managementunmatched
Code of Federal Regulationsunmatched
Computer Scienceunmatched
Data Cleaningunmatched
Data Collectionunmatched
Data Entryunmatched
Data Managementunmatched
Data Qualityunmatched
Document Archivingunmatched
Documentationunmatched
Electronic Data Capture (EDC)unmatched
GCP (Good Clinical Practices)unmatched
ICH Regulationsunmatched
Industry Standardsunmatched
Maintain Complianceunmatched
Medical Codingunmatched
Medical Dictionary for Regulatory Activities (MedDRA)unmatched
Problem Solving Skillsunmatched
Project/Program Managementunmatched
Quality Controlunmatched
Quality Metricsunmatched
Reconciliationunmatched
Regulationsunmatched
Risk Managementunmatched
Software Validationunmatched
Startupunmatched
Validation Testingunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.