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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