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    Associate Medical Director M-Serm

    Thermo Fisher Scientific
    2-5 years
    Not Disclosed
    Remote
    10 Sept. 11, 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 Description: Associate Medical Director M-SERM

    Company: Thermo Fisher Scientific Inc.

    Position Overview:

    Thermo Fisher Scientific Inc. is seeking a highly skilled and motivated Associate Medical Director to join our M-SERM (Medical Science and External Research Management) team. In this pivotal role, you will ensure the successful execution of clinical trials and support the development of life-saving therapeutics. As an Associate Medical Director, you will contribute significantly to the advancement of clinical research and the generation of critical medical insights.

    Job Requirements:

    • Educational Background: Graduate or Postgraduate Medical Degree (MD, MBBS).
    • Experience: 2-5 years of experience in life sciences or a medically related field.
    • Knowledge: Proficient in the clinical trial process and Good Clinical Practice (GCP).
    • Flexibility: Ability to work in the Europe Time Zone.
    • Preferred Experience: Clinical trial experience in specialties such as hematology/oncology, immunology, cardiology, renal, and endocrine diseases.

    Job Responsibilities:

    • Medical Data Review: Conduct real-time holistic reviews of medical data, including patient profiles and line listings, to identify anomalies and assess overall medical plausibility.
    • Aggregate Trend Analysis: Perform aggregate trend reviews and provide medical, clinical, and scientific inputs.
    • Dosing Records: Review investigation product dosing records to ensure protocol adherence and identify inaccuracies or missed dosages.
    • Adverse Events (AEs): Verify supporting information for reported AEs and identify missing or implausible data.
    • Concomitant Medications: Review all reported concomitant medications for protocol compliance.
    • Patient Criteria: Assess inclusion and exclusion criteria to ensure patient eligibility for clinical trials.
    • End-of-Study (EOS) Documentation: Ensure accurate EOS documentation to determine the primary reason for patient participation ending.
    • Laboratory Results: Review laboratory results for completeness and identify potential safety conditions.
    • Readiness Reviews: Perform necessary reviews to determine overall readiness of patient information for subsequent trial phases.
    • Study Start-Up: Participate in study start-up activities, including providing clinical inputs and creating checks in the DMP system and Spotfire visualization tool.
    • Team Collaboration: Maintain ongoing connectivity with the study team, resolve queries, and participate in meetings to provide scientific insights and support.

    Medical Judgement Focus:

    In this role, you will focus more on providing medical insights and less on project management. You will serve as the primary interface for medical discussions requiring judgement and scientific insight, thereby adding substantial value to the study.

    Why Join Us?

    At Thermo Fisher Scientific, we are committed to making the world healthier, cleaner, and safer. If you are a highly motivated individual with a proven track record in the life sciences field, we encourage you to apply. Join our diverse team and contribute to our mission of advancing scientific discovery and improving global health.

    Work Schedule:

    • Standard (Mon-Fri)

    Environmental Conditions:

    • Office-based

    Apply Today and Start Your Journey with Thermo Fisher Scientific!

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