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    Central Monitor (India)

    Innovaderm Research
    6-7 years
    Not Disclosed
    India
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Central Monitor Job Description

    Overview
    Centralized monitoring is an integral component of a risk-based monitoring strategy. It involves the timely, remote review of accumulating subject and operational data using analytics and statistical methods. The objective is to distinguish between reliable and unreliable data, identify trends, outliers, and unusual variability.

    The Central Monitor is responsible for conducting a holistic and centralized statistical review of study data from study initiation through database lock, as per the centralized monitoring plan. Using analytical tools, the Central Monitor identifies emerging and existing risks to critical study data and processes, enabling proactive risk identification, communication, escalation, and management at the study, country, and site levels.

    Responsibilities

    • Data Review

      • Follow established procedures for reviewing clinical trial data (Operational and Subject data) using tools and systems in alignment with the centralized monitoring plan.
      • Identify data quality trends indicative of systematic errors and potential performance issues at the study/country/site level.
      • Track evidence of issues and potential risks with the support of senior team members.

    • Documentation

      • Ensure results of reviews are appropriately documented per procedures.
      • Provide input to senior team members to support the development of risk characterization and reporting.

    • Support

      • Assist Central Monitoring teams in performing assigned reviews, ensuring high quality and timely results.
      • Support review set-up activities as directed by the lead, including database updates, pulling reports, and other assigned tasks.

    • Collaboration

      • Share responsibility for data quality at study, country, and site levels.
      • Collaborate with teams to ensure smooth workflow and adherence to quality standards.

    Requirements

    Education

    • Bachelor’s degree in a field relevant to clinical research.

    Experience

    • Minimum 1 year of experience in central statistical monitoring.
    • At least 6 years of experience in two or more operational areas such as:
      • Clinical monitoring
      • Data management
      • Drug safety
      • Medical monitoring
      • Biometrics
      • Project management
    • Basic understanding of:
      • Statistical monitoring and Risk-Based Quality Management (RBQM).
      • Processes associated with clinical study management, data management, and regulatory operations.

    Technical Skills

    • Proficiency in clinical trial database systems (e.g., EDC, IRT, CTMS).
    • Advanced computer skills, including MS Office (Word, Excel, PowerPoint).
    • Basic understanding of descriptive analysis (e.g., means, medians, significance, confidence intervals).
    • Familiarity with trending and analyzing site/study data using study documentation and electronic systems.

    Attributes

    • Fluent in English (excellent oral and written communication).
    • Strong prioritization and time-management skills.
    • Ability to work effectively in non-traditional environments.
    • Broad understanding of clinical trial roles, functions, and processes.
    • Knowledge of Good Clinical Practices (GCP) and regulatory guidelines (e.g., Health Canada, FDA).

    Work Environment

    At Innovaderm, we value:

    • Collaboration
    • Innovation
    • Reliability
    • Responsiveness

    Position Perks:

    • Permanent full-time role
    • Flexible schedule
    • Vacation benefits
    • Home-based position
    • Opportunities for ongoing learning and development

    About Innovaderm

    Innovaderm is a Contract Research Organization (CRO) specializing in dermatology. Founded in 2000 and headquartered in Montreal, Innovaderm has built a solid reputation for delivering high-quality research and services that exceed client expectations. Innovaderm continues to expand across North America and Europe, offering exciting opportunities for growth and innovation in the field of clinical research.

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