Clinical Trial Manager – Infectious Disease Diagnostics
Location: San Diego, California, United States
Category: Medical and Clinical Affairs
About Abbott
Abbott is a global healthcare leader dedicated to improving patient outcomes and helping people live healthier, fuller lives. Our innovative portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines. With over 114,000 employees serving patients in more than 160 countries, Abbott is recognized as a pioneer in healthcare solutions worldwide.
Abbott Rapid Diagnostics develops advanced in vitro diagnostic (IVD) solutions used in hospitals, laboratories, and clinics globally. These solutions provide essential clinical data that guide critical decisions for conditions ranging from infectious diseases and cancers to cardiovascular and metabolic disorders.
Position Overview
Abbott is seeking a Clinical Trial Manager to join our San Diego, California team within the Infectious Disease Division. This role will serve as the subject matter expert for clinical trials supporting rapid IVD studies, including 510(k) OTC submissions and dual 510(k)/CLIA waiver pathways.
The Clinical Trial Manager will oversee all aspects of clinical trial operations, including study design, site management, data integrity, regulatory compliance, and cross-functional collaboration. The position requires expertise in clinical trial management, regulatory frameworks, and diagnostic device workflows.
Key Responsibilities
Lead the development, review, and finalization of clinical trial protocols aligned with regulatory and scientific objectives.
Serve as the clinical subject matter expert for rapid IVD studies, including 510(k) OTC and dual 510(k)/CLIA waiver submissions.
Manage all phases of clinical trials, including start-up, site initiation, patient enrollment, monitoring, and study close-out.
Oversee clinical sites, reference laboratories, contract research organizations (CROs), and other external partners to ensure compliance with timelines, budgets, and quality standards.
Supervise electronic data capture (EDC) systems and electronic trial master file (eTMF) platforms to maintain data integrity and regulatory compliance.
Collaborate closely with cross-functional teams, including Regulatory Affairs, Quality Assurance, Biostatistics, and Program Management.
Ensure adherence to Good Clinical Practice (GCP), internal SOPs, and applicable regulatory requirements.
Support regulatory submissions by providing clinical documentation and responding to inquiries from regulatory agencies.
Mentor and guide junior clinical staff while promoting continuous process improvement initiatives.
Identify, assess, and mitigate risks throughout the clinical trial lifecycle.
Required Qualifications
Bachelor’s degree in Life Sciences, Clinical Research, or related field (Advanced degree preferred, e.g., MS, MPH, PhD).
Minimum 2 years of experience in clinical trial management, preferably in diagnostics or medical devices.
Strong knowledge of FDA regulations, including 21 CFR Parts 11, 50, and 812, and experience with 510(k) and CLIA waiver submissions.
Proven ability to manage multi-site clinical trials and collaborate effectively with CROs and external vendors.
Proficiency with clinical trial systems such as EDC and eTMF.
Excellent organizational, communication, and leadership skills.
Ability to work independently and collaboratively in a fast-paced, cross-functional environment.
Preferred Qualifications
Experience with IRB submissions for in vitro diagnostics and regulatory pathways for 510(k) OTC and dual 510(k)/CLIA waivers.
Minimum of 2 years’ experience conducting clinical research or laboratory-based scientific work.
Familiarity with regulatory submissions, clinical study design, and infectious disease diagnostics.
Compensation
Base Pay: $86,700 – $173,300 (may vary by location and experience)
Why Join Abbott
Access to career development opportunities in a global, innovative healthcare company.
Comprehensive healthcare and wellness benefits including medical, dental, vision, and occupational health programs.
Support for professional growth including tuition reimbursement and employee development programs.
Opportunity to work on impactful clinical trials that influence patient care and diagnostics worldwide.
Learn more about Abbott benefits at www.abbottbenefits.com.
Abbott is an Equal Opportunity Employer, committed to diversity, equity, and inclusion in the workplace.
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