Clinical Data Manager

Clinvigilant Research Pvt. Ltd.; Ahmedabad District; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Clinvigilant Research Pvt. Ltd. in Ahmedabad is seeking a detail-oriented Clinical Data Manager with 3-5 years of data management experience to oversee data throughout the study lifecycle.

The role includes reviewing study protocols, designing/evaluating eCRFs, performing data validation, and collaborating with cross-functional teams to ensure data integrity and compliant trial execution. The successful candidate will ensure adherence to ICH-GCP, CDISC standards, and regulatory requirements,

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 CRO/pharma/biotech environments.
• Experience with EDC systems such as Medidata Rave, Oracle InForm, or Veeva EDC.
• Knowledge of ICH-GCP, CDISC (CDASH/SDTM), regulatory guidelines.
• Proficiency in Excel and MS Office.

Responsibilities

• Manage end-to-end clinical data management activities for assigned studies per project timelines.
• Review study protocols and contribute to eCRF design, edit checks, and databases.
• Perform data validation, discrepancy management, and query resolution to ensure data quality.

Skills

Analytical skills

Attention to detail

Communication skills

Prioritisation

Cross-functional collaboration

Education

Bachelor's or Master's in Life Sciences / related discipline

Tools

Medidata Rave

Oracle InForm

Veeva EDC

Job description

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.