Clinical Data Manager

Clinvigilant Research Limited; Ahmedabad District; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Clinvigilant Research Limited seeks an experienced Clinical Data Manager to lead data management activities across oncology trials. The role requires hands-on expertise in CDISC SDTM, regulatory standards, and multiple EDC platforms.

You will collaborate with cross-functional teams to ensure high-quality, audit-ready data for submissions. The ideal candidate has 3–7 years of CDA experience in pharma/CRO settings and will mentor junior staff while helping shape data management best practices

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 in pharma, biotech, or CRO sectors.
• Experience managing oncology trials and CDISC SDTM delivery.
• Strong knowledge of ICH-GCP, FDA/EMA guidelines and regulatory expectations.

Responsibilities

• Manage end-to-end data management activities for Phase I–IV oncology trials.
• Develop and maintain DMPs, DVPs, CRF/eCRF specs, and database design docs.
• Coordinate start-up activities, protocol review, CRF design, and UAT.
• Oversee database build, testing, validation, and deployment with vendors.
• Perform data review, discrepancy management, query resolution, and data cleaning.
• Ensure CDISC SDTM compliance and prepare regulatory submissions.
• Collaborate with Clinical Operations, Biostatistics, Regulatory Affairs.
• Support inspections with audit-ready documentation.
• Monitor CRO/vendor performance and ensure timelines and quality.

Skills

Clinical Data Management

Oncology Clinical Trials

CDISC Standards

SDTM

Data Cleaning & Query Management

Database Design & UAT

External Data Reconciliation

MedDRA & WHO Drug Coding

ICH-GCP Compliance

Regulatory Submissions

Cross-functional Collaboration

Project Coordination

Education

Bachelor's or Master's degree in Life Sciences, Pharmacy, Biotechnology, Biostatistics, or a related discipline

Tools

Medidata Rave

Oracle InForm

Veeva CDMS

Oracle Clinical

Job description

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
• Data Cleaning and Query Management
• Database Design and UAT
• External Data Reconciliation
• MedDRA and WHO Drug Coding
• ICH-GCP Compliance
• Regulatory Submissions
• Cross-functional Collaboration
• Project Coordination