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 solid 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.





 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

 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

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

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

Pay: ₹32,000.00 - ₹68,000.00 per month

Benefits

- Flexible 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: 4 years (Preferred)
- Oncology: 1 year (Preferred)

Work Location: In person

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