Volibits | Data Specialist

3 days ago


bangalore, India Volibits Full time

Job Description: Central Statistical/Data Monitor (6-8) positions)/Remote/Pune/Bangalore

Experience: 3-6 years


Position Overview:

This role expects centralized monitoring and checks to ensure data integrity and mitigate risks across clinical trial sites. Experience on centralized monitoring techniques to detect data anomalies, identify site misconduct, and optimize site performance.


Key Responsibilities:


  • Data Evaluation and Analysis:
  • Perform centralized monitoring of site data in real time from a central location to assess risks and identify anomalies.
  • Utilize advanced statistical monitoring algorithms to detect outliers and inconsistencies across clinical trial data.
  • Analyze data from various sources, including baseline, clinical, laboratory, treatment, and patient-reported outcomes.


  • Risk-Based Monitoring (RBM):
  • Collaborate with cross-functional teams to implement RBM strategies, targeting site visits based on identified risks.
  • Inform Clinical Research Associates (CRAs) about site-specific risks and guide escalation and intervention strategies.


  • Process Improvement:
  • Develop and refine processes to enhance the detection of erroneous data and site misconduct.
  • Evaluate and improve the effectiveness of Key Risk Indicators (KRIs) through comprehensive data analysis.

Qualifications:

  • Bachelor’s degree or higher in Biostatistics, Data Science, Clinical Research, or a related field.
  • Proven experience in statistical monitoring, centralized monitoring, or clinical trial risk management.
  • Strong understanding of Risk-Based Monitoring (RBM) principles and practices.
  • Proficiency in statistical software (e.g., SAS, R, Python) and data visualization tools.
  • Familiarity with regulatory standards and guidelines in clinical research (e.g., ICH-GCP, FDA, EMA).


Preferred Skills:

  • Experience with Trial Master Plans (TMP) and communication plans.
  • Familiarity with clinical trial data types, including laboratory data, treatment data, and patient-reported outcomes.



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