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Clinical Trial Manager

2-3 years
$86,700 – $173,300
10 Nov. 12, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

🧬 Position Title: Clinical Trial Manager

Location: United States – California – San Diego
Category: Medical and Clinical Affairs
Company: Abbott


🌍 About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Its diverse portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 colleagues across 160+ countries, Abbott is committed to advancing health through innovation.


💼 Working at Abbott

Abbott offers an empowering environment where you can:

  • Do meaningful work that impacts lives globally

  • Grow your career with international opportunities

  • Care for yourself and your family with excellent benefits

  • Be your authentic self in an inclusive workplace

Employee Benefits Include:

  • Free medical coverage under the Health Investment Plan (HIP) PPO

  • High employer contribution to retirement savings plan

  • Tuition reimbursement and Freedom 2 Save student debt program

  • FreeU education benefit – affordable pathway to earn a bachelor’s degree

  • Recognized by Fortune as one of the World’s Most Admired Companies

  • Named among the Best Places to Work for diversity, mothers, female executives, and scientists


🚀 The Opportunity

The Clinical Trial Manager (CTM) will be based in San Diego, CA, within Abbott’s Infectious Disease Division (Abbott Rapid Diagnostics).
You will play a vital role in managing rapid in vitro diagnostic (IVD) clinical trials — supporting studies that aid in detecting diseases such as infectious disorders, cancers, heart conditions, and more.


🧩 Key Responsibilities

  • Serve as the subject matter expert (SME) for rapid IVD clinical studies, focusing on 510(k) OTC and dual 510(k)/CLIA waiver submissions.

  • Lead the development, review, and finalization of clinical protocols aligned with regulatory and scientific objectives.

  • Manage all aspects of clinical trial operations, including:

    • Study start-up

    • Site initiation

    • Patient enrollment

    • Monitoring and close-out

  • Oversee activities of clinical sites, reference labs, CROs, and external vendors — ensuring compliance with timelines, budgets, and quality.

  • Supervise and manage Electronic Data Capture (EDC) and electronic Trial Master File (eTMF) systems for data integrity and compliance.

  • Collaborate cross-functionally with Regulatory Affairs, QA, Biostatistics, and Program Management teams.

  • Contribute to strategic decision-making through core team participation.

  • Ensure adherence to GCP, FDA regulations, and internal SOPs.

  • Provide clinical documentation for regulatory submissions and respond to agency queries.

  • Identify and mitigate risks throughout the trial lifecycle.

  • Mentor junior staff and promote continuous process improvement.


🎓 Required Qualifications

  • Bachelor’s degree in Life Sciences or related field
    (Advanced degree — MS, MPH, or PhD preferred)

  • Minimum 2 years’ experience in clinical trial management, preferably in diagnostics or medical devices

  • Strong understanding of FDA regulations (21 CFR Part 812, 50, and 11)

  • Experience with 510(k) and CLIA waiver pathways

  • Proven success in multi-site trial management and vendor oversight

  • Proficiency in EDC and eTMF systems

  • Excellent organizational, communication, and leadership skills

  • Ability to work independently in a fast-paced, cross-functional environment


🌟 Preferred Qualifications

  • 2+ years’ experience with IRB submissions and 510(k) OTC/dual 510(k)-CLIA waiver regulatory pathways

  • 2+ years’ experience in conducting clinical research or related scientific laboratory work


💰 Compensation

  • Base Pay Range: $86,700.00 – $173,300.00
    (Range may vary by specific location)


🔗 Additional Information

Learn more about Abbott’s employee benefits:
👉 www.abbottbenefits.com

Connect with Abbott:
🌐 www.abbott.com
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🐦 Twitter @AbbottNews