Assoc Medical Data review Manager
1 month ago
Job Title / Primary Skill: Associate Medical Data Review Manager
Years of Experience: 2 + Years.
Job Location: Bangalore (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
- With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions
- Ensure timely follow-up and resolution of compliance issues
- Serve as Subject Matter Expert (SME)
- Serve as POC/ Back-up POC
- Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
- Provide therapeutic area/indication training for the project clinical team.
- Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
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 • Attention to detail
- Interpersonal and analytical skills,
- Must have Medical but also an operational focus towards metrics and status information to take the appropriate actions to resolve.
- Excellent communication, interpersonal, customer service, and teamwork skills. • Excellent organizational and problem-solving skills.
- Excellent project management skills and coaching skills.
- Ability to work with minimal supervision, using available resources,
- Ability to work on multiple projects and manage competing priorities
- Strong customer focus skills
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
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
PHYSICAL REQUIREMENTS
- Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
- Extensive use of keyboard requiring repetitive motion of fingers.
- Regular sitting for extended periods of time.
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