Katalyst CRO
Job Description
We are looking for a Clinical Data Manager at Katalyst CRO to lead and oversee all data management activities for assigned projects, including vendor selection and management, supervision of vendor‑delivered tasks, ensuring data integrity, accuracy, and quality, and collaborating closely with internal cross‑functional teams to maintain global data standards, support data governance initiatives, and ensure compliance with regulatory requirements.
Responsibilities
Independently perform study data management activities, ensuring timely and high‑quality data delivery.
Support Project Data Management Lead activities under the guidance of senior leadership, contributing to multi‑study or global programmes.
Oversee and manage all data management activities performed by external vendors, including CRF and database design, Data Management Plan development, data review guidelines, edit specifications, database lock (including SAE reconciliation, external data reconciliation, and dictionary term reconciliation).
Review deliverables to ensure adherence to project timelines, data quality standards, and compliance requirements.
Conduct data risk assessments and design proactive data quality strategies to mitigate risks throughout the study lifecycle.
Ensure that clinical data is collected, cleaned, and formatted according to applicable standards for analysis, reporting, and regulatory submissions.
Ensure final datasets meet submission readiness and compliance standards.
Track key data management metrics and timelines; communicate progress and risks to cross‑functional teams and project management to ensure KPIs are met.
Collaborate with internal teams and partner companies to gather and verify trial data for submission; propose alternatives when data gaps are identified.
Collaborate with cross‑functional teams (Clinical Operations, Biostatistics, Medical Monitoring, etc.) to ensure alignment and efficiency in data management processes.
Interface with internal stakeholders and external partners on protocol review, CRF logic and consistency, clinical study reports (CSRs), and statistical analysis plans (SAPs).
Participate in discussions with global teams, including regular engagement with Japanese headquarters regarding global data management procedures, standards, and strategy.
Monitor industry trends in data management and contribute to the continuous improvement of processes and tools.
Review and approve appropriate dictionary versions (e.g., MedDRA, WHO Drug).
Archive end‑of‑study documents as appropriate.
Requirements
Bachelor’s degree in data management, Life Science, Technology, Engineering, Mathematics, or a related field is required; an advanced degree is highly preferred.
Minimum of five (5) years of experience in clinical data management within the pharmaceutical, biotechnology, or CRO sectors.
At least two (2) years of experience in a lead role overseeing study‑level data management activities, including vendor oversight and cross‑functional collaboration.
Proven experience with CRO/vendor management, including performance tracking and deliverable review.
Hands‑on experience supporting or leading database lock activities, query management, data reconciliation, SAE handling, and external data integration.
Deep understanding of clinical data management principles and regulatory requirements (ICH‑GCP, 21 CFR Part 11, GDPR, HIPAA, etc.) and how they relate to data quality, integrity, and audit readiness.
Strong understanding of Risk‑Based Quality Management (RBQM) principles and their application in data management workflows.
Proficient in clinical trial data standards (CDISC CDASH and SDTM) and practical application in study design and submission deliverables.
Solid working knowledge of medical coding dictionaries (MedDRA and WHO Drug), including code review, consistency checks, and upgrades.
Demonstrated expertise in Electronic Data Capture (EDC) systems, particularly Medidata Rave; working knowledge of other EDC platforms (Oracle InForm, Veeva) is a plus.
Proficient in clinical data systems and tools (data visualization/reporting platforms, data reconciliation tools).
Familiarity with Computerized System Validation (CSV) processes and regulatory expectations.
Strong proficiency in Microsoft Office applications (Excel, Word, PowerPoint, Outlook) and ability to generate reports, dashboards, and presentations for stakeholders.
Basic knowledge of Decentralized Clinical Trials (DCT) models and emerging technologies such as Artificial Intelligence (AI) in data management.
Excellent written, oral communication and presentation skills.
#J-18808-Ljbffr
Responsibilities
Independently perform study data management activities, ensuring timely and high‑quality data delivery.
Support Project Data Management Lead activities under the guidance of senior leadership, contributing to multi‑study or global programmes.
Oversee and manage all data management activities performed by external vendors, including CRF and database design, Data Management Plan development, data review guidelines, edit specifications, database lock (including SAE reconciliation, external data reconciliation, and dictionary term reconciliation).
Review deliverables to ensure adherence to project timelines, data quality standards, and compliance requirements.
Conduct data risk assessments and design proactive data quality strategies to mitigate risks throughout the study lifecycle.
Ensure that clinical data is collected, cleaned, and formatted according to applicable standards for analysis, reporting, and regulatory submissions.
Ensure final datasets meet submission readiness and compliance standards.
Track key data management metrics and timelines; communicate progress and risks to cross‑functional teams and project management to ensure KPIs are met.
Collaborate with internal teams and partner companies to gather and verify trial data for submission; propose alternatives when data gaps are identified.
Collaborate with cross‑functional teams (Clinical Operations, Biostatistics, Medical Monitoring, etc.) to ensure alignment and efficiency in data management processes.
Interface with internal stakeholders and external partners on protocol review, CRF logic and consistency, clinical study reports (CSRs), and statistical analysis plans (SAPs).
Participate in discussions with global teams, including regular engagement with Japanese headquarters regarding global data management procedures, standards, and strategy.
Monitor industry trends in data management and contribute to the continuous improvement of processes and tools.
Review and approve appropriate dictionary versions (e.g., MedDRA, WHO Drug).
Archive end‑of‑study documents as appropriate.
Requirements
Bachelor’s degree in data management, Life Science, Technology, Engineering, Mathematics, or a related field is required; an advanced degree is highly preferred.
Minimum of five (5) years of experience in clinical data management within the pharmaceutical, biotechnology, or CRO sectors.
At least two (2) years of experience in a lead role overseeing study‑level data management activities, including vendor oversight and cross‑functional collaboration.
Proven experience with CRO/vendor management, including performance tracking and deliverable review.
Hands‑on experience supporting or leading database lock activities, query management, data reconciliation, SAE handling, and external data integration.
Deep understanding of clinical data management principles and regulatory requirements (ICH‑GCP, 21 CFR Part 11, GDPR, HIPAA, etc.) and how they relate to data quality, integrity, and audit readiness.
Strong understanding of Risk‑Based Quality Management (RBQM) principles and their application in data management workflows.
Proficient in clinical trial data standards (CDISC CDASH and SDTM) and practical application in study design and submission deliverables.
Solid working knowledge of medical coding dictionaries (MedDRA and WHO Drug), including code review, consistency checks, and upgrades.
Demonstrated expertise in Electronic Data Capture (EDC) systems, particularly Medidata Rave; working knowledge of other EDC platforms (Oracle InForm, Veeva) is a plus.
Proficient in clinical data systems and tools (data visualization/reporting platforms, data reconciliation tools).
Familiarity with Computerized System Validation (CSV) processes and regulatory expectations.
Strong proficiency in Microsoft Office applications (Excel, Word, PowerPoint, Outlook) and ability to generate reports, dashboards, and presentations for stakeholders.
Basic knowledge of Decentralized Clinical Trials (DCT) models and emerging technologies such as Artificial Intelligence (AI) in data management.
Excellent written, oral communication and presentation skills.
#J-18808-Ljbffr