Assoc Medical Data review Manager

2 days ago

Bengaluru Karnataka India, Karnataka IQVIA Full time

Job Title / Primary Skill: Associate Medical Data Review Manager

Years of Experience: 2 + Years.

Job Location: Bangalore/Thane (Hybrid)

Educational qualification: MBBS/MD is a must.


Job Overview:

  • Serve as a Subject level Data reviewer (SLDR) and identify any anomalies in patient reported data by performing Subject
  • Level Data Review that requires further investigation with the clinical site to determine overall accuracy
  • Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
  • Provide project management to the team in the area of Project Management and viewed as an expert in data management.
  • Drive the delivery of end-to-end study data quality and integrity.
  • Provide medical, clinical, and scientific advisory expertise.
  • May act as a clinical data scientist for performing data analytics by reviewing the visualizations, identify potential issues of concern and present at multi-disciplinary team meetings and external meetings.
  • Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance. .
  • Define data capture requirements in line with protocol and reporting needs.
  • Maintain strong customer relationships
  • Ensure timely follow-up and resolution of compliance issues
  • Serve as Subject Matter Expert (SME)
  • Serve as POC/ Back-up POC


REQUIRED KNOWLEDGE, SKILLS AND ABILITIES


  • Good understanding of clinical/medical data.
  • Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology.
  • Proven expertise in the proactive identification of issues.
  • Demonstrated ability to plan, organize and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time based metrics.
  • Proven ability to work within a matrix team environment requiring minimum level of supervision


MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • MBBS or MD with 2 + years of work experience.
  • Experience in clinical data sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience

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