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    Senior Clinical Project Specialist - Structural Heart

    Abbott
    3+ years
    $72,700.00 – $145,300.00
    Minneapolis and St. Paul, Minnesota. Plano Sylmar
    10 Nov. 25, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    Abbott - Senior Clinical Project Specialist (Structural Heart)

    Location: Varies by location (Typically office-based or remote with travel requirements)

    Company Overview:

    Abbott is a global healthcare leader dedicated to helping people live fuller lives through innovative healthcare technologies. With 114,000 colleagues serving over 160 countries, Abbott’s life-changing products span diagnostics, medical devices, nutritionals, and branded generic medicines.

    Position Overview:

    Abbott’s Structural Heart business is seeking a Senior Clinical Project Specialist to join its Study Operations Project Management team. This role will support the execution of Abbott's clinical device studies by ensuring compliance with study protocols, Good Clinical Practices (GCP), applicable regulatory standards, and Abbott Standard Operating Procedures (SOPs). The position will focus on study management support activities, including vendor oversight and managing study documentation.

    Key Responsibilities:

    • Study Management Support:

      • Assist Clinical Project Manager with the execution of study tasks.
      • Maintain study-specific SharePoint sites and study-level Trial Master File (TMF).
      • Develop and manage study-related materials, including training slides, document templates (e.g., DoA, training logs), newsletters, and patient recruitment materials.
      • Review and ensure completeness of site activation checklists and regulatory documents.

    • Collaboration and Communication:

      • Support site selection and vendor coordination processes.
      • Work with committees, vendors, core labs, and internal stakeholders (e.g., Clinical Project Manager, Field Clinical, Medical Directors) to ensure study progress.
      • Provide periodic updates on site and/or study statuses as requested by the Clinical Project Manager.
      • Communicate with customers, KOLs (Key Opinion Leaders), Principal Investigators, and other internal teams.

    • Document Review and Coordination:

      • Review clinical study documents for accuracy and completeness, including site activation regulatory documents and study-related materials.

    • Other Support Tasks:

      • Support the development of study-specific educational materials (e.g., SIV slides, patient brochures).
      • Coordinate activities with internal teams and assist with general study execution tasks.

    Education and Experience:

    Required:

    • Bachelor’s degree in a relevant field (e.g., natural sciences, pre-medicine, nursing, bioengineering).
    • Minimum 3 years of experience in clinical operations or healthcare-related fields.
    • Strong written and verbal communication skills, with the ability to interpret clinical data and present findings clearly.
    • Proficiency in Microsoft Office Suite and relevant clinical applications.
    • Excellent organizational and problem-solving skills, with attention to detail.
    • Ability to work independently and meet deadlines.

    Preferred:

    • Familiarity with cardiac and vascular technologies.
    • Experience in clinical research or a clinical/hospital environment.
    • Certification as a Research Professional by the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP).

    Compensation and Benefits:

    • Base Pay: $72,700 – $145,300 (The pay range may vary depending on location).
    • Health & Wellness: Free medical coverage (HIP PPO medical plan) for employees who complete a short wellness assessment.
    • Retirement Savings Plan: Excellent employer contribution.
    • Tuition Reimbursement: Available for continuing education and development.
    • Work-Life Balance: Abbott promotes a healthy work-life balance with access to various wellness and family benefits.

    Why Work at Abbott?

    • Career Development: Abbott offers opportunities for career growth and professional development within a global company.
    • Diversity & Inclusion: Recognized as one of the best places to work, with a focus on diversity, working mothers, female executives, and scientists.
    • Impactful Work: Abbott’s products help thousands of people worldwide live healthier lives, from cardiac patients to those living with chronic conditions.

    This role is a fantastic opportunity for someone with clinical operations experience who wants to make an impact in the healthcare industry, working on cutting-edge heart disease treatments. If you're passionate about clinical research and thrive in a collaborative environment, Abbott could be the perfect place for you.

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