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-Senior Analyst, Clinical Data

4-7 years
Not Disclosed
10 Nov. 20, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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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