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Clinical Project Specialist - Medical Devices (Onsite)

2+ years
$65,900.00 – $131,900.00
10 Dec. 4, 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 Title: Clinical Project Specialist – Medical Devices

Location: Sylmar, California, USA (Onsite)
Category: Medical and Clinical Affairs
Employer: Abbott


Overview

Abbott is a global healthcare leader dedicated to helping people live healthier lives through innovative solutions across diagnostics, medical devices, nutrition, and branded generic medicines. The Clinical Project Specialist will play a vital role in supporting clinical operations for cardiac device studies, ensuring compliance with regulations, Good Clinical Practice (GCP), and company standards.


Key Responsibilities

  • Study Coordination:

    • Create and manage clinical study materials for site selection, qualification, and activation.
    • Oversee study close-out processes and maintain audit readiness.
    • Collaborate with Marketing to develop patient access materials promoting diversity and inclusion.
  • Communication & Documentation:

    • Prepare newsletters and submit reports to Central IRBs.
    • Maintain clinical study SharePoint sites and ensure accurate document management.
  • Third-Party Management:

    • Track deliverables from third-party suppliers and core labs.
    • Coordinate global site activation reviews and approvals.
  • Operational Support:

    • Define and implement document management plans.
    • Support Clinical Project Managers and cross-functional teams.

Required Qualifications

  • Education: Bachelor’s degree (Biological Sciences or Medical Specialty preferred).
  • Experience:
    • Minimum of 2 years in a related field, with knowledge of clinical operations and business practices.
    • Familiarity with regulations affecting implantable medical devices (e.g., GCP).
  • Skills:
    • Strong communication, organizational, and multitasking abilities.
    • Attention to detail and the ability to prioritize in a fast-paced environment.
    • Team-oriented with the ability to work independently when needed.

Preferred Qualifications

  • Background in implantable medical devices and matrixed business environments.
  • Experience managing diverse clinical projects with geographically dispersed teams.

Compensation & Benefits

  • Base Salary Range: $65,900 - $131,900 (may vary by location).
  • Comprehensive Health and Wellness Benefits, including free HIP PPO medical coverage (with completed assessment).
  • Retirement Savings Plan with generous employer contributions.
  • Tuition Reimbursement and student debt assistance.
  • Opportunities for career growth and international exposure.

Why Abbott?

  • Recognized as one of the most admired companies globally.
  • Committed to diversity, employee development, and creating a positive workplace.
  • A chance to contribute to life-changing innovations in healthcare.

Apply now to join Abbott and make a meaningful impact in medical and clinical advancements. For more information, visit Abbott Benefits.