Assoc medical data review manager
2 months ago
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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