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    Senior Officer

    Lambda Therapeutic Research
    5+ years
    Not Disclosed
    Ahmedabad
    10 Jan. 3, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Job Title: Senior Officer
    Company: Lambda Therapeutic Research Ltd.
    Location: Ahmedabad, India
    Date: January 3, 2025

    Organisational Overview

    Lambda Therapeutic Research Ltd. is a global contract research organization (CRO) that provides comprehensive services for pharmaceutical, biotechnology, and medical device industries. With a focus on improving health outcomes, Lambda assists clients in various aspects of clinical trials and regulatory compliance. The company is dedicated to delivering high-quality solutions and maintaining rigorous industry standards.

    Job Description

    The Senior Officer at Lambda Therapeutic Research Ltd. is responsible for providing quality system management assistance, ensuring compliance with investigational product regulations, and maintaining quality standards. The position involves providing direct QA support related to Lambda's training programs and nonconformance management, which includes deviation and CAPA programs. Additionally, the role includes data review, clinical trial documentation creation, and conducting quality control checks.

    Key Responsibilities

    • Quality System Management Assistance:
      • Provide support within the regulations of investigational products and quality standards, specifically 21 CFR Part 312, 21 CFR Part 211, ICH E6, and ISO standards.
      • Assist in creating, editing, and reviewing documentation related to operational procedures, QMS (Quality Management Systems), and other relevant activities.
    • Quality Assurance (QA) Responsibilities:
      • Support QA activities related to training programs and nonconformance management, including deviation programs and CAPA (Corrective and Preventive Actions).
    • Clinical Trial Data Entry and Review:
      • Enter clinical trial data into data collection tools and conduct data reviews for CRFs (Case Report Forms), eCRFs (electronic CRFs), and reports.
      • Perform quality control checks of clinical trial data, ensuring accuracy and completeness.
      • Generate, track, and close queries for images, reports, CRFs, eCRFs, etc.
      • Handle data/image transfers and conduct post-reader quality checks.

    Key Deliverables

    • Maintain compliance with regulatory standards related to clinical trials.
    • Ensure quality in clinical trial data entry, review, and query management.
    • Assist with nonconformance management, deviations, and CAPA implementation.
    • Provide QA support for Lambda's training programs and related processes.

    Experience

    • Minimum of 2 years in clinical imaging services.
    • At least 5 years of experience in clinical trials.
    • Strong attention to detail and ability to multitask under pressure.
    • Ability to prioritize workload and meet deadlines in a dynamic environment.

    Skills and Experience

    • Excellent oral and written communication skills.
    • Strong time management and organizational skills.
    • Ability to work in a team environment and independently when required.
    • Ability to maintain confidentiality and handle sensitive data.
    • Self-motivated with the ability to quickly grasp new concepts.
    • Experience with data entry and familiarity with clinical trial processes.
    • Expertise in using MS Office and internet applications.
    • Working knowledge of medical terminology is preferred.

    Educational Qualification

    • Bachelor’s degree or relevant experience in a related field is preferred.

    Competencies

    • Accountability: Strong responsibility for quality and compliance in all tasks.
    • Communication: Ability to clearly communicate across various stakeholders.
    • Work Ethic: Dedicated to high standards and operational efficiency.
    • Initiative: Proactive in identifying problems and offering solutions.
    • Leadership: Leadership and mentoring skills to work collaboratively.
    • Technical Knowledge: Expertise in clinical trials and quality assurance processes.
    • Time Management: Ability to prioritize effectively and meet deadlines.
    • Motivation & Initiative: Self-driven with a willingness to learn and adapt.
    • Interpersonal/Leadership Skills: Strong team collaboration and independent working skills.
    • Presentation/Communication Skills: Capable of presenting findings in a clear and concise manner.
    • Flexibility/Planning & Organizing: Highly organized and adaptable to change.

    How to Apply

    Interested candidates should submit their applications via Lambda Therapeutic Research Ltd.'s official career portal.

    Let me know if you need further details or assistance!

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