Clinical Data Manager

Job Title: Clinical Data Manager

Experience: 3-7 Years

Location:- Ahmedabad, WFO.

Employment Type: Full-time

No. of Position:-02

Position Summary

We are seeking an experienced Clinical Data Manager with 3–7 years of experience in clinical data management to support global clinical trials, with a strong focus on oncology studies. The ideal candidate will have hands-on experience in clinical data management processes, working knowledge of CDISC standards (SDTM), and expertise in ensuring high-quality clinical data that meets regulatory and industry standards.

Key Responsibilities

• Manage end-to-end clinical data management activities for Phase I–IV clinical trials, with emphasis on oncology studies.
• Develop, review, and maintain Data Management Plans (DMPs), Data Validation Plans (DVPs), CRF/eCRF specifications, and database design documentation.
• Participate in study start-up activities, including protocol review, CRF design, edit check specifications, and database UAT.
• Coordinate database build, testing, validation, and deployment with cross-functional teams and external vendors.
• Perform ongoing data review, discrepancy management, query resolution, and data cleaning to ensure data quality and integrity.
• Ensure compliance with CDISC standards, including working knowledge of SDTM and its impact on downstream clinical data processing and regulatory submissions.
• Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, and Regulatory Affairs throughout the study lifecycle.
• Review external data transfers, perform reconciliation activities (SAE, laboratory, imaging, and other external data), and resolve data discrepancies.
• Support database lock activities, ensuring all deliverables are completed according to timelines and quality standards.
• Contribute to inspection readiness by maintaining complete and audit-ready documentation.
• Monitor CRO/vendor performance and ensure adherence to project timelines and quality expectations.
• Identify process improvement opportunities and contribute to the development and implementation of data management best practices and SOPs.
• Mentor junior Clinical Data Managers and provide technical guidance where needed.

Required Qualifications

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Biostatistics, or a related discipline.
• 3–7 years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry.
• Experience managing oncology clinical trials.
• Strong understanding of ICH-GCP, FDA, EMA, and applicable regulatory requirements.
• Working knowledge of CDISC standards, particularly SDTM, and their application in clinical trials.
• Experience with EDC systems such as Medidata Rave, Oracle InForm, Veeva CDMS, Oracle Clinical, or similar platforms.
• Experience in database testing, edit check review, query management, and data reconciliation.
• Familiarity with coding dictionaries such as MedDRA and WHO Drug.
• Strong analytical, problem-solving, and communication skills.
• Ability to manage multiple studies and work effectively in cross-functional global teams.

Preferred Qualifications

• Experience with decentralized or hybrid clinical trials.
• Exposure to data visualization and reporting tools.
• Knowledge of ADaM and clinical data flow from collection through regulatory submission.
• Experience supporting regulatory inspections and audits.
• Certification in Clinical Data Management (e.g., CCDM) is an advantage.

Key Skills

• Clinical Data Management
• Oncology Clinical Trials
• CDISC Standards
• SDTM
• EDC Systems (Medidata Rave, Oracle InForm, Veeva CDMS)
• Data Cleaning and Query Management
• Database Design and UAT
• External Data Reconciliation
• MedDRA and WHO Drug Coding
• ICH-GCP Compliance
• Regulatory Submissions
• Vendor/CRO Management
• Cross-functional Collaboration
• Risk Management
• Project Coordination

For more details and for job application you can also refer our career page:-

https://www.clinvigilant.com/jobs/clinical-data-manager/