Clinical Data Management Role at IQVIA
Position Overview
Position Title: Clinical Data Management
Organization: IQVIA
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, Lifesciences
Experience Required: 2+ Years
Salary Range: ₹25,000 – ₹35,000 per month
Location: Hyderabad
About IQVIA
IQVIA is a global leader in providing clinical research services, commercial insights, and healthcare intelligence to life sciences and healthcare industries. The company accelerates the development and commercialization of innovative medical treatments to enhance patient outcomes and global population health.
Qualifications and Experience
Educational Requirements:
- Bachelor’s Degree in Life Sciences, Pharmacy, or related fields preferred.
Experience:
- 2+ years in Clinical Data Review tasks.
- Strong knowledge of clinical data management activities.
- Proficiency in clinical data listings review and vendor data reconciliation, including local lab review.
Core Responsibilities
- Data Management and Review:
- Understand and review protocols along with data review documents such as the Protocol Data Review Plan and Data Quality Management Plan.
- Perform data cleaning per defined Clean Patient Group and manage discrepancies.
- Query Management:
- Facilitate the resolution of data discrepancies and perform User Acceptance Testing (UAT) for data review listings.
- External Data Coordination:
- Coordinate with external data vendors to resolve discrepancies and ensure data integrity.
- Documentation and Compliance:
- File appropriate documents in the electronic Trial Master File (eTMF) as per the eTMF master plan.
- Ensure compliance with industry regulations, including ICH-GCP guidelines and 21 CFR Part 11.
Key Skills and Competencies
- Expertise in EDC Systems: Experience with Electronic Data Capture (EDC) systems, particularly Medidata RAVE.
- Proficiency in Veeva Vault Documentation: Skilled in managing clinical trial documentation using Veeva Vault.
- Understanding of Clinical Research: Basic knowledge of clinical research processes, including Investigator site operations.
- Communication Skills: Strong oral and written communication skills to interact effectively with cross-functional teams.
- Regulatory Knowledge: Familiarity with ICH-GCP guidelines, regulatory requirements, and data privacy regulations like 21 CFR Part 11.
Additional Skills (Nice to Have)
- Third-Party Reconciliation: Knowledge of third-party reconciliations such as Serious Adverse Event (SAE) Reconciliation, Protocol Deviation, and Questionnaire review.
- Study Build Aspects: Understanding of study build processes like Case Report Form (CRF) design and Edit Check build for efficient data review.
- UAT Expertise: Ability to perform UAT for screens and edit checks, ensuring proper discrepancy management.
Responsibilities Breakdown
Responsibility | Details |
---|---|
Protocol Review | Review protocols and relevant data review documents like Protocol Data Review Plan. |
Data Cleaning | Manage data cleaning per the Clean Patient Group, freeze, and lock CRFs/Fields. |
Discrepancy Resolution | Facilitate the resolution of data discrepancies with the Data Management Lead. |
External Data Management | Coordinate with external data vendors for discrepancy resolution. |
Documentation | File documents in eTMF as per the master plan. |
Vendor Data Reconciliation | Review local lab data and perform vendor data reconciliation. |
Query Management | Manage queries and discrepancies across projects. |
Why IQVIA?
Joining IQVIA means being part of a dynamic team that is transforming the healthcare and life sciences industries. With a commitment to innovation, IQVIA supports the development of medical treatments that improve patient care worldwide. This role offers a unique opportunity to contribute to groundbreaking clinical research in a supportive and growth-oriented environment.
Apply Now and take the next step in your career with IQVIA, where your expertise in clinical data management will make a meaningful impact on global health.