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 supervisionMINIMUM 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