We are seeking a detail-oriented and proactive Clinical Data Manager with 3-5 years of experience in clinical data management. The ideal candidate will be responsible for managing clinical trial data throughout the study lifecycle, ensuring high-quality, accurate, and compliant data. The role involves database design review, data validation, query management, data cleaning, and collaboration with cross-functional teams to support successful clinical study execution.

Key Responsibilities

 Manage end-to-end clinical data management activities for assigned clinical studies in accordance with project timelines.

 Review study protocols and contribute to the design and review of electronic Case Report

Forms (eCRFs), edit checks, and clinical databases.

 Perform data validation, discrepancy management, and query generation/resolution to ensure data quality, consistency, and completeness.

 Develop and execute data cleaning strategies, including routine data review and reconciliation activities.

 Review clinical trial data for accuracy, integrity, and compliance with study protocols, SOPs,

client requirements, and regulatory guidelines.

 Coordinate database User Acceptance Testing (UAT), database updates, and database lock activities.

 Generate data listings, reports, metrics, and study status summaries for internal and external stakeholders.

 Collaborate with Clinical Operations, Biostatistics, Medical Writing, Medical Monitoring, and external vendors to resolve data-related issues.

 Review and maintain Data Management Plans (DMPs), Data Validation Plans (DVPs), CRF

Completion Guidelines, and other study documentation.

 Support medical coding activities using MedDRA and WHO Drug dictionaries, where applicable.

 Ensure compliance with ICH-GCP, CDISC standards, SOPs, and applicable regulatory requirements.

 Participate in audit and inspection readiness activities and address data management findings.





 Prioritize workload effectively to meet project milestones and deliverables.

 Mentor or provide guidance to junior Clinical Data Management associates, as required.

Required Qualifications

 Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related discipline.

 3-5 years of experience in Clinical Data Management within a CRO, pharmaceutical, or biotechnology environment.

 Experience working with Electronic Data Capture (EDC) systems such as Medidata Rave,

Oracle InForm, Veeva EDC, or similar platforms.

 Good understanding of clinical trial processes, database management, and data cleaning methodologies.

 Knowledge of ICH-GCP, CDISC (CDASH/SDTM), and regulatory guidelines.

 Proficiency in Microsoft Excel and Microsoft Office applications.

Required Skills

 Strong analytical and problem-solving skills.

 Excellent attention to detail and commitment to data quality.

 Effective verbal and written communication skills.

 Ability to manage multiple studies and prioritize competing deadlines.

 Strong interpersonal and cross-functional collaboration skills.

Preferred Qualifications

 Experience supporting Phase I–IV clinical studies.

 Exposure to data reconciliation, external data management, and medical coding processes.

 Certification in Clinical Data Management or Clinical Research is desirable.

 Good to have a knowledge of CDISC/ SDTM

 Good to have a knowledge of oncology trials.

Interested candidates can send CV on (phone hidden) / [email protected]

You may also pass this vacancy to your friend/colleague or any relative if they are looking for job change

Pay: ₹25,000.00 - ₹60,000.00 per month

Benefits

- Versatile schedule
- Paid sick time
- Paid time off

Ability to commute/relocate:
- Makarba, Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Required)

Experience:
- Clinical Data Management: 3 years (Required)

Work Location: In person

📌 Clinical Data Manager (Makarba)
🏢 PrimEdge Workforce Solutions
📍 Makarba