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Senior Analyst Clinical Data

2+ years
Not Disclosed
10 Nov. 25, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Job Description: Clinical Data Management Lead

The Clinical Data Management Lead acts as a subject matter expert (SME) in clinical databases and data management, bridging technical and clinical needs for efficient study execution. This role ensures data integrity, compliance with standards, and effective collaboration with multidisciplinary teams, contributing to regulatory submissions and overall clinical trial success.


Key Responsibilities

1. Team Collaboration and Stakeholder Communication

  • Represent Data Management in Clinical Project Teams as the SME for databases and data management.
  • Translate business needs from Clinical Project Teams and shared service functions (e.g., Safety, Core Lab) into actionable technical requirements.
  • Identify, analyze, and resolve complex data issues by collaborating across teams.
  • Train end users (internal and external) on databases and maintain training documentation and records.
  • Support FDA and quality audits related to clinical databases and data management activities.

2. Database Development and System Maintenance

  • Collaborate with Database Developers, Analysts, and Programmers to ensure timely and high-quality database deliverables.
  • Translate business needs into technical specifications for eCRFs, edit checks, study notifications, and database customizations.
  • Perform functional and user acceptance testing for database components, ensuring accuracy and compliance with study protocols.
  • Ensure proper implementation and documentation of data validation and quality control measures.
  • Regularly review database accounts to maintain access integrity and security.

3. Standards Implementation and Innovation

  • Serve as a data management expert to ensure proper utilization of standards in collaboration with Biostatistics and Programming teams.
  • Recommend improvements to data management procedures, SOPs, and technology solutions.
  • Promote adherence to industry best practices and internal standards in all data management activities.

4. Data Cleaning and Database Lock/Freeze Management

  • Lead data cleaning efforts, working with Clinical Project Teams and Statistics to identify and resolve data discrepancies.
  • Plan and execute interim and final database locks, ensuring timely completion of tasks and resolving issues proactively.
  • Oversee all data review processes, including validation checks, query issuance, database QC, SAE reconciliation, medical coding, and database closure activities.
  • Create and utilize tools and reports to document and streamline data cleaning efforts.
  • Coordinate and document data freeze and lock activities with Clinical Project Teams, Biostatistics, and SAS Programmers.

5. Reporting and Documentation

  • Design custom reports and tools to support data review and issue resolution.
  • Document data validation, testing, and freeze/lock activities, ensuring compliance with SOPs and work instructions.

Qualifications

Education and Experience

  • Bachelor’s degree in a relevant field (e.g., Life Sciences, Data Management, Computer Science).
  • Extensive experience in clinical data management, database design, and EDC systems.

Skills and Competencies

  • Expertise in translating business requirements into technical specifications.
  • Proficiency with SQL, EDC platforms, and database management tools.
  • Strong analytical, organizational, and problem-solving skills.
  • Ability to collaborate effectively with cross-functional teams and communicate complex data requirements clearly.
  • Knowledge of regulatory standards (e.g., FDA, GCP) and experience supporting audits.

Why Join Us?

  • Dynamic Role: Influence critical aspects of clinical data management, from design to regulatory submission.
  • Collaborative Environment: Work with diverse teams and shared service functions to drive project success.
  • Innovative Focus: Contribute to improving standards and practices in data management.
  • Regulatory Impact: Play a key role in delivering high-quality data for regulatory submissions and clinical outcomes.

Apply now to become a driving force in ensuring the quality and integrity of clinical data for impactful healthcare innovations!