🔹 Job Title: Associate Data Team Lead
📍 Location: Pune, India (Hybrid)
🕓 Job Type: Full-Time
🆔 Job ID: R1505063
🏢 Organization: IQVIA
🌍 Additional Locations: Available
🔗 Apply Here: IQVIA Careers
🔹 Job Category: Clinical Data Management
🎓 Qualification: Bachelor’s Degree (Life Sciences / Pharmacy / Relevant Field Preferred)
💼 Experience: Minimum 6+ years in End-to-End Clinical Data Management
🔹 Key Responsibilities:
🧩 Clinical Data Management
Manage all aspects of Clinical Data Management (CDM) — from protocol review, CRF design, to database lock, following SOPs.
Draft EDC build timelines and create Database & Edit Check specifications.
Create test scripts and perform User Acceptance Testing (UAT) for Coding, Site Payment, and Safety Gateway.
Conduct and facilitate EDC Build Kick-off, Interactive eCRF Builds, and Interactive Review Meetings (IRM).
Collaborate with Data Management Lead (DML) to ensure timely and quality study delivery.
Perform post-production/migration activities, if applicable.
📘 Documentation & Compliance
Prepare, review, and maintain CDM-related documents:
Data Quality Management Plan (DQMP)
Data Validation Plan (DVP)
Data Review Plan (DRP)
eCRF Completion Guidelines
Protocol Data Review Plan (PDRP)
Ensure timely filling in eTMF as per eTMF Master Plan.
Update study documents throughout study conduct.
Ensure compliance with GCP, 21 CFR Part 11, data privacy regulations, and IQVIA SOPs.
🧪 Data Review & Quality
Coordinate data review activities and monitor data health metrics.
Support Clean Patient Group delivery along with CDM staff.
Co-chair Data Quality Review (DQR) meetings with cross-functional teams.
Lead or support Health Authority inspections and audits.
🤝 Cross-Functional Collaboration
Liaise with external data vendors for escalations and data-related issues.
Represent Data Management in cross-functional and submission teams.
Coordinate with Clinical, Biostatistics, Programming, and Regulatory teams to meet study deliverables.
📈 Project Management & Leadership
Support DML in project management tasks, ensuring study timelines and quality targets are achieved.
Exhibit strong metrics analysis and reporting skills.
Provide training, mentoring, and coaching to junior CDM staff.
Ensure continuous improvement in CDM processes and standards.
🔹 Must Have Skills:
Clinical Data Management – End-to-End
EDC Systems (Medidata RAVE preferred, Oracle Clinical)
Query Trend Analysis & Protocol Deviation Reporting
Data Management Documentation (DQMP, DVP, DRP)
Data Integrity & Good Documentation Practices (GDP)
FDA/ICH Guidelines, NDA/BLA/MAA Submission Requirements
Vendor Oversight & Metrics Reporting
Project Management & Cross-Functional Leadership
Excellent Communication & Analytical Skills
🔹 Nice to Have:
Knowledge of ICH-GCP, Regulatory Guidelines, and 21 CFR Part 11
Understanding of Data Privacy Regulations
Knowledge of Project Planning and Management Methods
CCDM Certification (Certified Clinical Data Manager)
🔹 Educational Requirements:
Bachelor’s Degree (Life Sciences / Pharmacy / Relevant Field) – Required
Advanced Degree (M.Sc, M.Pharm, or equivalent) – Preferred
🔹 About IQVIA:
IQVIA is a global leader in clinical research, real-world evidence, and healthcare analytics, enabling smarter decision-making and accelerating medical innovation. Our mission is to advance human health by combining data science, technology, and domain expertise to deliver intelligent healthcare solutions.
🌐 Learn more: https://jobs.iqvia.com
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