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 2–5 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 maintain Data Management Plans (DMPs).
- Design, validate, and maintain Case Report Forms (CRFs/eCRFs) in Electronic Data Capture (EDC) systems.
- Perform data validation, discrepancy management, and query resolution to ensure high-quality datasets.
- Oversee database lock and data reconciliation processes.
- Collaborate with clinical, biostatistics, and regulatory teams to ensure compliance with CDISC/CDASH/SDTM standards.
- Manage external data sources (e.g., laboratory, imaging, ePRO, wearables) and integrate them into the clinical database.
- Ensure adherence to ICH-GCP, FDA, EMA, and GDPR regulations.
- Participate in audits and regulatory inspections as required.
Required Qualifications & Skills:
- Bachelor’s/Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related fields.
- 2–5 years of experience in Clinical Data Management within a CRO, Pharma, or Biotech company.
- Hands-on experience with EDC systems (e.g., Medidata Rave, Oracle InForm, Veeva Vault).
- Proficiency in CDISC/CDASH/SDTM standards and coding dictionaries (e.g., MedDRA, WHO-DD).
- Strong understanding of data validation, discrepancy management, and query resolution.
- Knowledge of ICH-GCP, FDA, and EMA guidelines.
- Ability to work in cross-functional teams and manage multiple tasks efficiently.
- Strong analytical skills with attention to detail.
Why Join Endpoint Data Analytics?
- Work with a dynamic and innovative team in the clinical research industry.
- Opportunity to contribute to high-impact clinical trials.
- Career growth in a fast-evolving data analytics environment.
- Competitive salary and benefits as per industry standards.
How to Apply?
Send resume to hr@epda.in
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