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    Medical Project Coordinator- Fsp

    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

    Work Schedule:
    Standard (Monday-Friday)

    Environmental Conditions:
    Office-based

    Job Description:

    Summarized Purpose:
    The Senior Clinical Process Associate assists in managing and evaluating medical projects for one or more programs. Working alongside management and stakeholders, the role ensures alignment, consistency, and compliance with internal processes while optimizing project performance and resolving issues throughout the project lifecycle.

    Essential Functions:

    • Coordinate and review safety data using line listings, company dashboards, and visualization tools. Identify safety trends, coding inconsistencies, and follow up with investigator sites as necessary.
    • Review safety data and provide summaries for safety review meetings.
    • Assist in reviewing sections of aggregate reports.
    • Help create and review safety and medical management plans for studies, ensuring they reflect contracts and requested services.
    • Assist with routine project implementation, forecasting, and coordination, including reviewing metrics and budget considerations.
    • Monitor data review status and escalate delays or risks to all stakeholders, including study leads.
    • May present at business development, client, and investigator meetings, and participate in strategy/business development calls.
    • Resolve complex problems through in-depth evaluation and provide solutions.
    • Serve as the primary point of contact for clinical/data management project teams as needed.
    • Assist management in training and mentoring team members.

    Qualifications:

    • Undergraduate or graduate degree in life sciences or related fields (e.g., Pharm D, PhD, BS in Science, RN, DDS).
    • 2-5 years of experience in the life sciences or medically related field.
    • Knowledge of clinical trials and Good Clinical Practice (GCP).
    • Experience in the therapeutic area of the clinical trials being supported.

    Knowledge, Skills, and Abilities:

    • Experience with aggregate trend-level reviews and investigation product dosing records.
    • Expertise in clinical inputs on risk assessment tools, creating L2/L3 & Centralized Statistical Monitoring (CSM) checks in DMP systems, and Spotfire visualization.
    • Strong knowledge of GCPs for medical oversight of clinical trials and Serious Adverse Event (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.
    • Excellent communication skills, both oral and written.
    • Attention to detail and ability to work collaboratively in a team environment.
    • Ability to maintain professionalism and a positive demeanor in challenging situations.

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