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    Manager - Scientific Affairs / Medical Services

    Lambda Therapeutic Research
    3-5 years
    Preferred by Comapny
    Ahmedabad
    12 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

    Job Title: Manager - Scientific Affairs / Medical Services

    Location: Ahmedabad, India
    Company: Lambda Therapeutic Research Ltd.

    About Lambda Therapeutic Research Ltd.

    Lambda Therapeutic Research Ltd. is a globally recognized Clinical Research Organization (CRO) with headquarters in Ahmedabad, India. With a presence in Mehsana (India), Las Vegas (USA), Pittsburgh (USA), Toronto (Canada), London (UK), and Warsaw (Poland), Lambda offers comprehensive clinical research services across the innovator, biotech, and generic pharmaceutical industries.

    Lambda has achieved significant milestones, including acquiring Novum Pharmaceutical Research Services in 2019 to expand its North American presence. The company has earned accolades such as the ‘Best Indian CRO’ by Frost & Sullivan, the ‘Regulatory Excellence’ Award at the CPhI Awards 2023, and ‘Industry Partner of the Year’ at the Global Generics & Biosimilar Awards 2023.

    These accomplishments reflect Lambda's commitment to regulatory excellence, industry leadership, and impactful collaboration.

    Position Overview

    The Manager - Scientific Affairs/Medical Services plays a pivotal role in ensuring the scientific and medical integrity of clinical studies. This position involves acting as a medical monitor, collaborating with cross-functional teams, and maintaining compliance with Good Clinical Practices (GCP) and regulatory standards.

    Key Responsibilities

    Scientific and Clinical Knowledge

    • Maintain expertise in specific disease areas relevant to assigned studies.
    • Keep abreast of clinical study documentation, regulatory requirements, and operational procedures.
    • Conduct eligibility reviews for assigned studies.

    Medical Monitoring

    • Act as the medical monitor for assigned studies, serving as a clinical point of contact for cross-functional teams and stakeholders.
    • Perform or oversee ongoing medical reviews of study data, including identifying trends, outliers, and protocol violators.
    • Conduct clinical reviews and address relevant medical inquiries.

    Collaboration and Communication

    • Participate in clinical study team meetings and present updates at department, project, and corporate meetings.
    • Collaborate with Lead Medical Monitors (Lead-MM) during study setup, conduct, recruitment activities, and reporting.
    • Assist in site inspections, readiness activities, investigator meetings, and site training as required.

    Regulatory and Ethical Compliance

    • Adhere to ICH/GCP guidelines and demonstrate ethical conduct at all times.
    • Ensure study data and activities comply with clinical research and regulatory standards.

    Allied Responsibilities

    • Demonstrate knowledge of clinical research methodology, biostatistics, and the drug development process.
    • Exhibit excellent interpersonal, communication, and influencing skills.
    • Maintain business acumen in clinical research industry functions and roles.
    • Deliver professional presentations and leverage Microsoft Office and virtual platforms effectively.

    Experience & Skills Required

    Experience

    • 0-2 years of experience in clinical research within an academic or industry setting (pharmaceutical, biotech, or CRO).

    Educational Qualifications

    • Bachelor’s degree in clinical medicine is required; advanced degrees such as MD are preferred.

    Technical Skills

    • Proficiency in Microsoft Office (Word, Excel, PowerPoint) and virtual platforms.
    • Strong analytical and organizational skills to manage complex clinical research processes.

    Soft Skills

    • Effective verbal and written communication skills.
    • Ability to influence without authority and foster collaboration.
    • Capability to travel domestically up to 30% of the time.

    Competencies

    • Accountability: Take responsibility for clinical study outcomes.
    • Communication: Demonstrate clarity and professionalism in interactions.
    • Leadership: Guide teams with initiative and strategic direction.
    • Flexibility: Adapt to evolving study requirements and environments.
    • Planning & Organizing: Prioritize tasks for efficient and effective study execution.

    Why Join Lambda?

    At Lambda, we are committed to creating a supportive work environment that values excellence, innovation, and collaboration. This role offers an opportunity to contribute to impactful clinical research while advancing your career in a globally recognized organization.

    Be part of a team that shapes the future of healthcare through dedication, expertise, and cutting-edge solutions.

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