Associate Medical Data Review Manager

Job Title - Associate Medical Data Review Manager

Location - Bangalore and Thane

Work Mode - Hybrid (3days WFO and 2 days WFH in a week)

Education qualification - MBBS/MD is a must.

PURPOSE

Provide expert skills as part of a Medical Data Review team to provide efficient, quality Medical Data Review products that meet customer needs.

RESPONSIBILITIES

• Serve as a Subject level Data reviewer (SLDR) and Identify any anomalies in patient reported data by performing Subject level Data Review that require 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

Medic with 5 year college degree or MBBS; or MD with 2+ years of clinical or non clinical experience required.

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.