Clinical Data Manager

Job Description:
The Clinical Data Manager is responsible for leading and overseeing all data management activities for assigned projects. This includes the selection and management of external data management vendors, supervision of vendor-delivered tasks, and ensuring the integrity, accuracy, and quality of clinical and operational data. The role also involves close collaboration with internal cross-functional teams to establish and maintain global data standards, support data governance initiatives, and ensure compliance with departmental procedures and regulatory requirements.
Responsibilities:

• Independently perform Study Data Management activities, ensuring timely and high-quality data delivery.
• Support Project Data Management Lead (PDML) activities under the guidance of senior leadership, contributing to multi-study or global programs.
• 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).
• rchival of 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 (e.g., Master's in Related disciplines) is highly preferred.
• Minimum of five (5) years of experience in clinical data management within the pharmaceutical, biotechnology, or CRO is required.
• t 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, including ICH-GCP, 21 CFR Part 11, and data privacy regulations (e.g., GDPR, HIPAA), and their connection 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, including CDISC CDASH and SDTM, and practical application in study design and submission deliverables.
• Solid working knowledge of medical coding dictionaries, such as 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 (e.g., Oracle InForm, Veeva) is a plus.
• Proficient in clinical data systems and tools, such as data visualization/reporting platforms, and tools for data reconciliation.
• Familiarity with Computerized System Validation (CSV) processes and regulatory expectations.
• Strong proficiency in Microsoft Office applications (Excel, Word, PowerPoint, Outlook) with the ability to generate reports, dashboards, and presentations for various stakeholders.
• Basic knowledge of Decentralized Clinical Trials (DCT) models and emerging technologies such as Artificial Intelligence (AI) in the context of data management.
• Excellent written, oral communication and presentation skills.