Assoc Medical Data review Manager

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