Clinical Data Specialist

2 days ago


Lucknow, Uttar Pradesh, India beBeeData Full time ₹ 80,00,000 - ₹ 1,20,00,000

Clinical Data Specialist

We are seeking a skilled Clinical Data Specialist to lead clinical data management activities across assigned clinical trials. The ideal candidate will ensure high-quality data acquisition, database design, and data integrity.

Key Responsibilities:
  • Lead clinical data management activities across assigned clinical trials.
  • Ensure high-quality data acquisition, database design, and data integrity.
  • Act as a technical resource for Data Management (DM) and Risk-Based Monitoring (RBM) standards, tools, and reporting.
  • Collaborate with cross-functional teams, external vendors, and internal stakeholders to ensure timely, compliant, and efficient data management processes.
  • Ensure study-specific documentation is complete and maintained in the Trial Master File (TMF).
  • Support data cleaning, integrity monitoring, e-data processing, and database release according to SOPs and industry best practices.
Qualifications:
  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Clinical Research, or related field.
  • 3+ years of experience in Clinical Data Management within the pharmaceutical or CRO industry.
  • Strong knowledge of EDC systems, clinical trial processes, and regulatory compliance (ICH-GCP).
  • Experience in Risk-Based Monitoring (RBM), data cleaning, and data visualization tools.
  • Excellent analytical, communication, and problem-solving skills.
What You Will Do:

You will lead clinical data management activities across assigned clinical trials, ensuring high-quality data acquisition, database design, and data integrity. You will act as a technical resource for Data Management (DM) and Risk-Based Monitoring (RBM) standards, tools, and reporting.

You will collaborate with cross-functional teams, external vendors, and internal stakeholders to ensure timely, compliant, and efficient data management processes.

Requirements:
  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Clinical Research, or related field.
  • 3+ years of experience in Clinical Data Management within the pharmaceutical or CRO industry.
  • Strong knowledge of EDC systems, clinical trial processes, and regulatory compliance (ICH-GCP).
  • Experience in Risk-Based Monitoring (RBM), data cleaning, and data visualization tools.
  • Excellent analytical, communication, and problem-solving skills.

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