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    Clinical Trial Assistant

    Planet Pharma
    3+ years
    Not Disclosed
    Remote, USA
    10 May 21, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Clinical Project Manager

    Major Accountabilities:

    1. Project Planning, Management, and Oversight:
      • Develop project plans and manage timelines for Clinical contributions to CV initiative.
      • Draft core team meeting agendas and ensure meeting outcomes are captured.
      • Contribute to management presentations highlighting scope, timeline, risks, and mitigation steps.
    2. System Specifications:
      • Participate in workshops and meetings to document application requirements.
      • Translate requirements into use cases and advocate for high priority needs of end users.
    3. Process Flows:
      • Determine how deployment of system functionality affects existing business processes.
      • Ensure any major process implications are understood and vetted in advance.
    4. Reporting:
      • Ensure standard reports within applications are specified, tested, and functioning.
      • Interface with core team and end-users to enable timely operational oversight.
    5. System Design & Configuration:
      • Interface with technical development team to ensure specifications are understood.
      • Lead review of initial prototypes and advocate for end users to ensure high priority requirements are met.
    6. System Testing and Release:
      • Provide input to testing plan and ensure applications meet desired requirements.
      • Partner with core team on clear go/no go criteria for system release to production.
    7. Training:
      • Provide input to training and change management plan and aid in coordination of training sessions.
    8. Desk Side Support:
      • Provide desk side support to answer user questions and log system "bugs" for remediation.
    9. Communication Plan:
      • Develop communication plan to keep stakeholders informed of clinical trial management activities.

    Qualifications:

    • Experience: Minimum of 3 years of experience in clinical operations or related field.
    • Education: Bachelor's degree in a scientific or healthcare-related field, or equivalent experience.
    • Software Proficiency: Proficient in using Clinical Trial Management Systems, preferably Veeva CTMS, and electronic Trial Master File (eTMF) software, preferably Veeva eTMF.
    • Skills:
      • Strong attention to detail and organizational skills.
      • Excellent written and verbal communication skills.
      • Ability to work collaboratively in a cross-functional team environment.
      • Knowledge of Good Clinical Practice (GCP) and applicable regulations.
      • Familiarity with country-specific regulatory requirements and site-level operational challenges.
    • Certification: Certification is a plus, at least some significant experience with Veeva is required.

    Employer-provided:

    Pay Range in United States: Exact compensation may vary based on skills, experience, and location.

    Base Salary: $43/hr - $45/hr

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