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    Senior Clinical Database Programmer

    Pharmalex
    0-2 years
    Not Disclosed
    Hyderabad Remote
    10 Feb. 10, 2025
    Job Description
    Job Type: Remote 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

    Senior Clinical Database Programmer
    Location: India-Hyderabad-Remote
    Job ID: R0000030883
    Category: Data Management

    Role Overview

    The Senior Clinical Database Programmer provides technical expertise for the conduct of clinical trials, focusing on eClinical technologies and clinical systems. This role may involve acting as an internal subject matter expert and providing technical support and guidance across various programming activities. The Senior Database Programmer works independently and is accountable for ensuring first-time quality in database setup, programming, and system integration within clinical trials.

    Key Responsibilities

    Database Set-Up and Maintenance

    • Lead, supervise, and/or create procedures to set up and maintain Electronic Data Capture (EDC) systems for clinical trials (paper-based and/or web-based).
    • Ensure database builds in Clinical Data Management Systems (CDMS) are in compliance with standard formats or CDISC-compliant formats.
    • Implement consistency checks and ensure adherence to regulatory requirements for database builds.
    • Oversee the creation of eCRFs, ensuring alignment with SOPs and internal process guidelines.
    • Provide input and negotiate database setup timelines, ensuring adherence.

    Project Support and Coordination

    • Monitor project resourcing, identify scope changes, and support project teams in resolving issues.
    • Interact with sponsors and Data Management Leaders on programming-related concerns.
    • Provide technical support and advice to internal teams.
    • Manage multiple projects simultaneously and lead programming activities related to clinical systems and applications within eClinical technologies.
    • Ensure lock/unlock of databases in compliance with guidelines and SOPs.

    System Integration and Technical Support

    • Support the integration of systems within the Global Data Operations (GDO) area (e.g., Clinical Trial Management System, Safety Systems, Coding Systems).
    • Ensure adherence to service level agreements (SLAs) regarding turnaround times for completed specifications.
    • Provide technical solutions to internal or external inquiries.

    Documentation and Compliance

    • Maintain all supporting documentation for studies in accordance with SOPs, Work Instructions, and regulatory requirements.
    • Ensure traceability and regulatory compliance in documentation, including the documentation of any deviations.
    • Maintain technical documentation for the Clinical Database.

    Support Initiatives and Process Improvement

    • Contribute to the creation of standards, tools, and processes within the GDO to improve efficiency and optimize workflows.
    • Develop and implement project-specific tools, such as standard directories and reports.
    • Mentor and provide training to staff and project teams as needed.
    • Assist in resolving daily work problems and provide technical solutions.

    Business Development and Client Interaction

    • Support bid defense meetings and engage in business development activities.

    Skills and Competencies

    • Leadership: Ability to lead and collaborate with global teams and work independently, especially in a virtual environment.
    • Interpersonal Skills: Strong communication skills, both oral and written, tailored to the audience with a diplomatic approach.
    • Problem Solving: Strong problem-solving skills and the ability to make decisions in ambiguous situations.
    • Time Management: Excellent prioritization and time management skills to meet objectives and deadlines.
    • Customer Focus: Ability to interact professionally and respectfully with colleagues and clients to build rapport and trust.
    • Quality Commitment: Methodical and accurate approach to work, ensuring first-time quality.
    • Adaptability: Ability to swiftly understand new systems and processes in an evolving technical environment.

    Knowledge and Experience

    • Programming Environments: Experience in at least one programming environment (e.g., SAS, CDMS, EDC, SQL, VB, Java).
    • Clinical Systems Knowledge: Experience with at least two systems used in the clinical trial process (e.g., SAS, CDMS, EDC: Inform, RAVE, DataLabs, Medrio, Veeva, CTMS, Medical Safety Reporting).
    • Regulatory Knowledge: Knowledge of SOPs, ICH-GCP, 21 CFR Part 11, and applicable local/international regulations.
    • Clinical Research Industry: Strong experience in the clinical research industry or a similar field.
    • Software Development Life Cycle (SDLC): Understanding of SDLC methodologies.

    Education

    • Degree: Bachelor's degree (or equivalent) in a relevant science discipline, or equivalent work experience.

    #LI-REMOTE

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