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    Manager - Scientific Affairs / Medical Services

    Lambda Therapeutic Research
    0-2 years
    Not Disclosed
    Ahmedabad
    10 Jan. 3, 2025
    Job Description
    Job Type: Full Time Education: MD 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: Manager - Scientific Affairs / Medical Services
    Company: Lambda Therapeutic Research Ltd.
    Location: Ahmedabad, India
    Date: December 24, 2024

    Organisational Overview

    Lambda Therapeutic Research Ltd. is a leading Clinical Research Organization (CRO) that provides comprehensive clinical research services to the global biotech, pharmaceutical, and generics industries. With a strong presence across India, North America, and Europe, Lambda has earned global recognition for its regulatory excellence and significant contributions to the clinical research sector. The company is committed to high standards of service and has garnered numerous awards, including being named the "Best Indian CRO" and receiving the "Regulatory Excellence" Award at the CPhI Awards 2023.

    Job Description

    Lambda Therapeutic Research Ltd. is looking for a Manager - Scientific Affairs / Medical Services to play a key role in managing scientific and clinical affairs related to ongoing clinical studies. The ideal candidate will maintain up-to-date knowledge in the specific disease areas of assignment, participate in clinical study team meetings, oversee medical monitoring activities, and contribute to clinical data review and other activities to ensure the smooth execution of clinical trials.

    Key Responsibilities

    • Medical Monitoring:

      • Serve as the medical monitor for assigned studies, being the clinical point of contact for cross-functional teams and stakeholders.
      • Oversee medical monitoring activities, including medical review of study data according to the medical data review plan.
      • Conduct clinical review of study data, identifying trends, outliers, protocol violators, and medical inquiries.

    • Clinical Study Team Participation:

      • Participate in clinical study team meetings and other interactions for ongoing project updates.
      • Present results and updates at department, project, corporate, and scientific meetings.
      • Partner with the Lead Medical Monitor (Lead-MM) to execute program/study activities, such as study setup, recruitment, conduct, and closeout.

    • Site Support:

      • Visit study sites as needed for inspection readiness, site initiation, investigator meetings, and other activities related to the study.

    • Clinical Research Knowledge:

      • Stay current with Good Clinical Practices (GCP), clinical research methodologies, the drug development process, and biostatistics.
      • Ensure ethical standards are upheld and maintain the highest level of professionalism.

    Allied Responsibilities

    • Core Clinical Research Knowledge:

      • Strong understanding of GCP, the drug development process, clinical research methodologies, and biostatistics.

    • Ethics and Communication:

      • Demonstrate the highest personal and ethical standards.
      • Ability to communicate effectively and influence others without authority.

    • Business Acumen:

      • Knowledge of the clinical research industry, drug development processes, and various functions involved.

    • Technology and Travel:

      • Proficient in Microsoft Office and virtual platforms.
      • Ability to travel domestically (up to 30% of total work time).

    Experience

    • Required: 0-2 years of progressively responsible experience in clinical research, ideally in an academic research institute or within the pharmaceutical, biotech, or CRO industry.

    Educational Qualification

    • Required: A minimum of a bachelor’s degree in clinical medicine (MD preferred).

    Competencies

    • Accountability: Strong responsibility for clinical research deliverables.
    • Communication: Excellent verbal and written communication skills.
    • Work Ethic: Demonstrates diligence and commitment to high-quality work.
    • Initiative: Proactive in tackling challenges and seizing opportunities.
    • Leadership: Ability to lead and influence others in cross-functional teams.
    • Technical Knowledge: Expertise in clinical research, GCP, and the drug development process.
    • Motivation/Initiative: Self-driven with a willingness to learn and improve.
    • Interpersonal/Leadership Skills: Collaborative and influential, working well in team environments.
    • Presentation Skills: Ability to present information clearly and effectively.
    • Flexibility/Planning & Organizing: Ability to adapt and plan work efficiently.

    How to Apply

    Interested candidates are encouraged to apply via Lambda Therapeutic Research Ltd.'s official career portal.

    Let me know if you need more information or assistance!

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