Job Title: Clinical Data Manager

Experience: 5-7 Years

Location:- Ahmedabad, WFO.

Employment Type: Full-time

No. of Position:-02

Position Summary

We are seeking an experienced Clinical Data Manager with 5–7 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.
- 5–7 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.
- Solid 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/

📌 Clinical Data Manager (Ahmedabad)
🏢 Clinvigilant Research
📍 Ahmedabad