Endpoint Data Analytics Pvt. Ltd. is a leading player in the clinical research and data analytics domain, specializing in delivering high-quality data management solutions for pharmaceutical, biotechnology, and CRO industries. With a strong commitment to compliance and innovation, the company supports clinical trials by ensuring data accuracy, integrity, and regulatory adherence.
Job Description: Clinical Data Analyst – II
Endpoint Data Analytics Pvt. Ltd. is seeking a skilled Clinical Data Analyst – II with 2β5 years of experience to oversee data management activities in clinical trials. The ideal candidate will ensure data accuracy, integrity, and compliance with regulatory standards while collaborating with cross-functional teams.
Key Responsibilities:
- Develop, review, and maintainΒ Data Management Plans (DMPs).
- Design, validate, and maintainΒ Case Report Forms (CRFs/eCRFs)Β inΒ Electronic Data Capture (EDC) systems.
- PerformΒ data validation, discrepancy management, and query resolutionΒ to ensure high-quality datasets.
- OverseeΒ database lock and data reconciliationΒ processes.
- Collaborate with clinical, biostatistics, and regulatory teams to ensure compliance withΒ CDISC/CDASH/SDTM standards.
- ManageΒ external data sourcesΒ (e.g., laboratory, imaging, ePRO, wearables) and integrate them into the clinical database.
- Ensure adherence toΒ ICH-GCP, FDA, EMA, and GDPRΒ regulations.
- Participate inΒ audits and regulatory inspectionsΒ as required.
Required Qualifications & Skills:
- Bachelorβs/Masterβs degreeΒ in Life Sciences, Pharmacy, Biotechnology, or related fields.
- 2β5 years of experienceΒ inΒ Clinical Data ManagementΒ within a CRO, Pharma, or Biotech company.
- Hands-on experience withΒ EDC systemsΒ (e.g., Medidata Rave, Oracle InForm, Veeva Vault).
- Proficiency inΒ CDISC/CDASH/SDTM standardsΒ and coding dictionaries (e.g., MedDRA, WHO-DD).
- Strong understanding ofΒ data validation, discrepancy management, and query resolution.
- Knowledge ofΒ ICH-GCP, FDA, and EMA guidelines.
- Ability to work inΒ cross-functional teamsΒ and manage multiple tasks efficiently.
- StrongΒ analytical skillsΒ with attention to detail.
Why Join Endpoint Data Analytics?
- Work with aΒ dynamic and innovative teamΒ in the clinical research industry.
- Opportunity to contribute toΒ high-impact clinical trials.
- Career growthΒ in a fast-evolving data analytics environment.
- Competitive salary and benefitsΒ as per industry standards.
How to Apply?
Send resume to hr@epda.in

