Senior Analyst Clinical Data

3-5 years

Not Disclosed

New Delhi

10 Dec. 4, 2024

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

Job Title: Senior Analyst Clinical Data

Location: New Delhi, India
Category: Medical and Clinical Affairs

Position Overview

The Senior Analyst Clinical Data serves as the subject matter expert in clinical database and data management, ensuring high-quality deliverables for clinical projects. The role involves collaborating with cross-functional teams, driving database development, managing data quality, and supporting regulatory submissions.

Key Responsibilities

Clinical Database Management

Represent Data Management in Clinical Project Teams, translating business needs into technical requirements.
Collaborate with shared service functions (Safety, Core Lab, etc.) for requirement gathering.
Identify, analyze, and resolve complex data issues through collaboration with project teams.
Develop and quality control (QC) data management documents such as data management plans and validation protocols.
Ensure compliance with data management standards, SOPs, and best practices.

Database Development and Maintenance

Partner with database developers and programmers to deliver technical solutions for EDC, edit checks, reports, and study notifications.
Translate study needs into technical specifications and perform functional and user acceptance testing (UAT).
Implement data validation specifications and ensure QC checks meet study requirements.
Communicate timelines and deliverables to stakeholders effectively.

Regulatory Support and Audits

Assist in FDA and quality audits involving Clinical Database and Data Management.
Lead data cleaning and database lock efforts for regulatory submissions.
Strategize and monitor data review, cleaning, and closure activities in line with SOPs.

Data Quality and Reporting

Lead data review meetings with Clinical Project Teams and Biostatistics to address data cleaning issues.
Utilize SQL and existing tools to design reports, monitor data quality, and resolve data discrepancies.
Document data freeze activities and collaborate with stakeholders for database lock.

Training and Process Improvement

Train end users on database functionalities and maintain training records.
Recommend process improvements for SOPs and work instructions.
Regularly review and ensure database access and security integrity.

Required Qualifications

Experience in clinical data management, including EDC systems and regulatory submission processes.
Proficiency in SQL, data cleaning, and quality control measures.
Strong collaboration and communication skills to manage cross-functional deliverables.

Preferred Skills

Expertise in designing and testing databases, edit checks, and reporting tools.
Familiarity with FDA audit requirements and clinical data validation practices.
Proven ability to manage multiple priorities and meet tight deadlines.

Why Join Us?

Be part of a dynamic team driving clinical innovation.
Contribute to high-impact projects in medical and clinical affairs.
Opportunity for professional growth and cross-functional collaboration.

Apply now to make a difference in advancing healthcare innovation!

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