Clinical Data Manager

Job Title: Clinical Data Manager

Experience: 3-5 Years

Location:- Ahmedabad, WFO.

Employment Type: Full-time

Job Summary

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.

Prioritise workload effectively to meet project milestones and deliverables.

Mentor or guide 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 prioritise competing deadlines.

Strong interpersonal and cross-functional collaboration skills.

Preferred Qualifications

Experience supporting Phase IIV 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 knowledge of CDISC/ SDTM

Good to have knowledge of oncology trials.

Looking for an immediate joiner to 30 days of Notice Period. .