Senior Analyst, Clinical Data
Location: New Delhi, India
Department: Medical and Clinical Affairs
Experience Required: 4–7 years in Clinical Data Management, EDC systems, and clinical operations
Job Overview
ThePharmaDaily.com is seeking an experienced Senior Analyst, Clinical Data to support global clinical programs by leading end-to-end clinical data management activities. This role requires strong expertise in clinical databases, data standards, EDC systems, and cross-functional collaboration within clinical research environments.
Key Responsibilities
Clinical Data Management Leadership
Serve as the primary Data Management expert on Clinical Project Teams.
Participate in project team meetings to gather business requirements and translate them into detailed technical specifications.
Collaborate with cross-functional partners such as Safety, Core Lab, Biostatistics, and Programming to align on data and system requirements.
Identify, analyze, and resolve complex data issues using sound judgment and proactive communication.
Conduct training for end users (internal and external) on clinical databases and maintain automated training systems.
Manage and maintain all clinical database and systems training documentation and records.
Support FDA inspections and quality audits involving clinical data and database processes.
Lead the creation and quality control of key Data Management documents including data management plans, data review guidelines, and validation protocols.
Ensure compliance with Standard Operating Procedures, data management standards, and industry best practices.
Clinical Database and System Development
Partner with Data Management leadership, Database Developers, Analysts, and Programmers to ensure timely delivery of database and system components.
Translate operational and scientific needs into technical specifications for eCRFs, edit checks, study notifications, and database customizations.
Perform and document functional testing and user acceptance testing for study databases, reports, and system customizations.
Ensure correct implementation of data validation logic and quality control checks as per study design.
Communicate clearly with project teams regarding timelines, deliverables, risks, and mitigation strategies.
Collaborate with the broader Data Management team to prioritize workload and deliverables.
Work closely with Biostatistics and Programming to ensure correct and consistent application of data standards.
Manage and regularly review database access accounts to ensure data integrity and security.
Recommend enhancements to SOPs, work instructions, and technology tools to improve operational efficiency.
Data Cleaning, Review, and Database Lock
Lead data review meetings with Clinical Project Teams and Biostatistics to plan and execute data cleaning activities.
Develop project plans for interim and final database locks, ensuring all data management tasks are executed within timelines.
Oversee all aspects of data review including validation checks, query generation, database QC, SAE reconciliation, medical coding, and closure activities.
Design tools and reports to support data cleaning, documentation, and review workflows.
Lead and document data freeze activities in collaboration with project teams, statisticians, and programmers.
Use existing tools, reports, SQL, and database interfaces to detect data discrepancies and drive timely resolution.
Required Qualifications
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Computer Science, or a related field.
4–7 years of experience in Clinical Data Management within pharma, biotech, CRO, or medical device sectors.
Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva, or equivalent).
Strong understanding of GCP, ICH guidelines, and regulatory requirements for clinical data.
Proficiency in SQL, data validation, and database testing methodologies.
Excellent communication, analytical, and documentation skills.
Proven ability to manage multiple studies and deadlines simultaneously.
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Japan | Saitama |Tokyo :
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