Clinical Data Management Job at Biotech Healthcare
Are you searching for a rewarding Clinical Data Management Job in the healthcare and clinical research sector? Here is an exciting opportunity from Biotech Healthcare for professionals passionate about clinical trials, data quality, and regulatory compliance. This opening is ideal for candidates looking to establish a strong Life Science Career in clinical affairs and healthcare research. With hands-on exposure to CRFs, eCRFs, clinical documentation, and data validation, this role offers an excellent opportunity for life science graduates to work in a professional and fast-growing biotech environment.
About Biotech Healthcare
Biotech Healthcare is a growing healthcare and biotechnology organization focused on innovation, clinical excellence, and patient-centered solutions. The company works across healthcare, pharmaceuticals, and clinical research domains while promoting diversity and equal employment opportunities. Biotech Healthcare provides excellent career growth for professionals seeking a stable and impactful Life Science Career in India.
Job Details:
- Job Title: Clinical Data Management Specialist
- Department: Clinical Affairs
- Company: Biotech Healthcare
- Location: Ahmedabad
- Employment Type: Full-Time
About the Role
Biotech Healthcare is seeking a Clinical Data Management Specialist to support clinical studies through effective management of clinical data collection, validation, review, documentation, and compliance activities.
The role involves working closely with cross-functional teams to ensure high-quality, accurate, and audit-ready clinical data management processes aligned with study protocols, company SOPs, GCP guidelines, and regulatory requirements.
Role Objective
The Clinical Data Management Specialist will:
- Support clinical data collection and management activities
- Assist in CRF/eCRF development and review
- Perform data validation and query management
- Maintain study documentation and compliance records
- Ensure data integrity, quality, and timely study deliverables
Eligibility Criteria
Educational Qualification
Candidates should possess one of the following:
- M.Sc. in:
- Life Sciences
- Clinical Research
- Related healthcare or clinical disciplines
Experience Requirements
Candidates should have:
- 2–5 years of experience in:
- Clinical Data Management
- Clinical Research
- Clinical Affairs
- CRO/Site Data Coordination
- eCRF/CRF Handling
- Clinical Documentation Activities
Key Responsibilities
Clinical Data Management Activities
The selected candidate will:
- Assist in designing and developing:
- Case Report Forms (CRFs)
- Electronic Case Report Forms (eCRFs)
- Ensure CRFs align with finalized study protocols
- Support preparation and maintenance of:
- Data Management Plans (DMPs)
- SOPs
- Work instructions
- Controlled documentation
Data Review & Validation
Responsibilities include:
- Reviewing clinical data for:
- Discrepancies
- Missing data
- Inconsistencies
- Protocol deviations
- Generating and resolving queries in a timely manner
- Performing:
- Data validation
- Data verification
- Reconciliation support
- Quality control checks
- Supporting:
- Edit checks
- Database testing/UAT
- Data cleaning
- Database lock readiness
Documentation & Compliance
The role also includes:
- Maintaining:
- Query logs
- Trackers
- Audit-ready records
- Version-controlled study documents
- Ensuring compliance with:
- GCP guidelines
- Company SOPs
- Regulatory requirements
- ALCOA+ principles
- Coordinating with:
- Clinical Operations
- Regulatory teams
- QA
- Biostatistics
- Medical Writing
- Vendors and investigators
Functional Skills Required
Preferred competencies include:
- Understanding of:
- Clinical trial processes
- Study lifecycle management
- Database lock and close-out activities
- Knowledge of:
- CRF/eCRF design
- Query management
- Data cleaning
- Validation processes
- Clinical documentation standards
- Familiarity with:
- EDC/eCRF systems
- MS Office tools
- Clinical data standards
Behavioral Skills Required
Candidates should demonstrate:
- Strong written and verbal communication skills
- High attention to detail and documentation discipline
- Time management and multitasking abilities
- Problem-solving mindset
- Confidentiality and integrity
- Team collaboration and adaptability
Reporting Structure
| Particular | Details |
| Reporting To | AGM – Clinical Affairs |
| Team Structure | Individual Contributor |
