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    Medical Monitor

    Syngene
    2-5 years
    Not Disclosed
    Bangalore
    10 Jan. 29, 2025
    Job Description
    Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Medical Monitor

    Date: 19 Jan 2025
    Job Location: Bangalore
    Department: Clinical Development – Medical & Regulatory Affairs
    Pay Grade: 
    Years of Experience: 2-5 years

    About Syngene

    Syngene International Ltd., incorporated in 1993, is an innovation-driven global discovery, development, and manufacturing organization. The company provides integrated scientific services to sectors like pharmaceuticals, biotechnology, nutrition, animal health, consumer goods, and specialty chemicals. Syngene serves world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its team of 4,240+ scientists works with global clients to address scientific challenges, improve R&D productivity, accelerate time-to-market, and reduce innovation costs.

    Job Description

    The Medical Monitor (or Associate Research Physician/Associate Manager) will play a pivotal role in overseeing clinical trial-related projects across various therapeutic areas, ensuring that clinical data are medically accurate and comply with regulatory requirements. This role involves reviewing, interpreting, and analyzing safety and clinical data to ensure quality in medical documentation.

    Key Responsibilities

    Clinical Trial Support & Medical Review

    1. Medical Data Review & Interpretation:

      • Review and interpret clinical and safety data to ensure accuracy and appropriate medical context.
      • Ensure data are presented in alignment with regulatory requirements, internal SOPs, and medical guidelines.

    2. Protocol Documentation Support:

      • Assist in the preparation and review of clinical protocol appendices, including the Investigator’s Brochure, Informed Consent Document, Investigator’s Undertaking, and Clinical Study Report (CSR).
      • Provide input into the MedDRA and WHO Drug Insight coding for clinical trial projects as needed.

    3. Safety Reporting & Analysis:

      • Support Senior Research Physician in generating Serious Adverse Event (SAE) narratives.
      • Perform quality review and analysis of adverse events, and ensure proper communication to stakeholders as per internal guidelines and timelines.
      • Take the lead in preparing the Integrated Summary of Safety and Efficacy for clinical trials.

    4. Protocol & Study Design Review:

      • Collaborate with clinicians, bioanalytical personnel, biostatisticians, regulatory affairs personnel, and medical monitors to review protocols and protocol synopses for Bioavailability (BA)/Bioequivalence (BE) and Phase studies.

    5. Medical Monitoring Plan (MMP):

      • Prepare the Medical Monitoring Plan (MMP) and Risk Evaluation and Mitigation Strategy (REMS) when applicable for clinical trials.

    6. Site Feasibility & Study Team Training:

      • Prepare Site Feasibility Questionnaires (SFQs) for patient-based studies.
      • Provide training to the study team and address protocol-related queries in a timely manner.

    7. Regulatory Documentation Support:

      • Ensure that deliverables meet accuracy and timelines, supporting the completion of quality regulatory documents.

    8. Document Management:

      • Manage documents through multiple review cycles, meeting deadlines and ensuring accuracy.

    Qualifications

    Educational Qualifications:

    • MBBS with an MD in Pharmacology or equivalent.

    Experience:

    • 2-5 years of experience in clinical trials, medical review, or related areas.

    Behavioral Skills

    • Communication: Strong verbal and written communication skills.
    • Team Collaboration: Ability to work effectively in a team-oriented environment.
    • Adaptability: Capable of thriving in dynamic, ambiguous settings and adapting to changing circumstances.
    • Time Management: Ability to meet tight deadlines and effectively prioritize tasks.
    • Problem-Solving: Creative thinking and development of innovative solutions.
    • Focus: Detail-oriented and focused on quality.

    Equal Opportunity Employer

    Syngene is committed to equal employment opportunities (EEO) for all individuals. The company does not discriminate based on age, color, national origin, disability, race, religion, gender, sexual orientation, gender identity, genetic information, marital status, veteran status, or any other protected characteristic. Syngene will provide reasonable accommodations for qualified individuals with disabilities.

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