The Clinical Data Management (CDM) role targets professionals with 1–2 years of experience in clinical data handling. It is based in Nagpur, Maharashtra, with priority given to local candidates. Accurate clinical data management ensures reliable trial outcomes and regulatory compliance in medical device research.
About the Company
Bioexcel is a Contract Research Organization (CRO) headquartered in Nagpur, India. It specializes in services for medical devices and in-vitro diagnostics (IVDs). The company supports clinical investigations, data management, regulatory submissions, and post-market follow-up. It operates in compliance with standards such as ISO 14155, EU MDR, IVDR, FDA, and CDSCO. Bioexcel focuses on areas including cardiology, orthopedics, neurology, and oncology devices.
Job Overview
This entry-level position involves managing clinical trial data for medical device studies. Candidates handle data processes in a specialized CRO environment. The role contributes to generating evidence for device safety and performance.
- Hands-on involvement in real-world medical device trials.
- Support for database management and regulatory documentation.
- Collaboration with clinical and regulatory teams.
Key Responsibilities
- Perform clinical data entry, validation, and query management.
- Review Case Report Forms (CRFs) and conduct data cleaning.
- Handle database operations and related documentation.
- Assist in clinical trial data reconciliation processes.
- Ensure compliance with Good Clinical Practice (GCP) and applicable regulatory guidelines.
Eligibility & Skills
- Bachelor’s or Master’s degree in Life Sciences (B.Sc./M.Sc.), Clinical Research, or Allied Health Sciences.
- 1–2 years of experience in Clinical Data Management.
- Strong knowledge of clinical data management processes.
Why This Role Matters
Clinical data management forms the foundation of credible evidence in medical device trials. It directly impacts the quality of data used for regulatory approvals and device safety assessments. In a specialized CRO like Bioexcel, accurate CDM supports compliance with global standards such as EU MDR and ISO 14155. This ensures trial data reliably demonstrates device performance and patient safety outcomes.
Benefits & Exposure
This position offers practical experience in managing data from medical device clinical investigations. Team members work on ongoing trials, gaining insight into device-specific data challenges. Guidance from experienced professionals in clinical research and regulatory affairs is provided. Exposure includes biostatistics, data reconciliation, and GCP-compliant processes in a focused med-tech setting.
Career Path After This Role
With experience gained here, professionals often advance to senior CDM roles within CROs. Opportunities may include data management leads or positions in biostatistics and regulatory data submission. Further progression can lead to clinical research coordination or quality assurance in medical device organizations.
How to Apply
Interested candidates should send their updated CV to hr@bioexcelife.com. Include relevant experience in clinical data management.
