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    Medical Project Coordinator

    Thermo Fisher Scientific
    2+ years
    Not Disclosed
    Remote, USA
    10 July 19, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 Summary:

    The Medical Project Coordinator assists in the management and ongoing evaluation of medical projects for one or more programs. This role ensures consistency, alignment, and compliance of internal processes, as well as optimal performance and issue resolution throughout the project lifecycle.

    Essential Functions:

    • Safety Data Coordination:

      • Coordinate and review safety data using line listings, company dashboards, and other visualization tools.
      • Review data for safety trends, coding consistencies, and potential follow-up with investigator sites.
      • Identify potential issues and resolve or escalate as appropriate.

    • Safety Reviews:

      • Review safety data and provide summations for safety review meetings.
      • Review designated sections of aggregate reports.
      • Create and review safety and medical management plans for studies, ensuring processes reflect contract and requested services.

    • Project Management:

      • Manage routine project implementation, forecasting, and coordination, including reviewing metrics and budget considerations.
      • Monitor the status of data review and escalate any delays or risks to stakeholders, including study leads.

    • Business Development:

      • Present at business development, client, and investigator meetings.
      • Participate in strategy and business development calls.

    • Problem Solving:

      • Resolve complex problems through in-depth evaluation of various factors and offer solutions.

    • Communication and Training:

      • Serve as the primary point of contact for clinical/data management project teams.
      • Assist management in training and mentoring.

    Qualifications:

    Education and Experience:

    • Bachelor’s degree in Nursing or related Health Sciences (Physician's Assistant) or licensed RN.
    • Minimum of 2 years of experience in clinical safety, clinical research monitoring, or pharmacovigilance.
    • Equivalent combinations of education, training, and directly related experience may be considered.

    Knowledge, Skills, and Abilities:

    • Knowledge of GCPs for medical oversight of clinical trials and SAE processing.
    • Understanding of drug development and safety reporting.
    • Proficiency in safety data trending and coding.
    • Working knowledge of biostatistics, data management, and clinical procedures.
    • Strong problem-solving and critical thinking skills.
    • Good oral and written communication skills.
    • Attention to detail.
    • Ability to work in a collaborative team environment.
    • Ability to maintain a positive and professional demeanor in challenging circumstances.

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