Clinical Trial Manager – Rapid Diagnostics
Location: San Diego, CA, USA
Category: Medical & Clinical Affairs | Employment Type: Full-Time | Travel: Up to 10%
Company Overview:
Abbott is a global healthcare leader committed to improving lives through innovative medical devices, diagnostics, nutritionals, and branded generics. With a presence in over 160 countries, Abbott empowers clinicians, laboratories, and patients to make informed decisions with high-quality healthcare solutions.
Role Overview:
We are seeking a Clinical Trial Manager for Abbott Rapid Diagnostics’ Infectious Disease Division. This role is responsible for overseeing the design, execution, and management of multi-site clinical trials for rapid in-vitro diagnostic products. The Clinical Trial Manager ensures adherence to regulatory requirements, Good Clinical Practice (GCP), and internal standards while working closely with cross-functional teams to support product development and regulatory submissions.
Key Responsibilities:
Lead the design, review, and finalization of clinical protocols for 510(k) OTC and dual 510(k)/CLIA waiver pathways.
Manage all aspects of clinical trial operations including study start-up, site initiation, patient enrollment, monitoring, and study close-out.
Oversee clinical sites, reference labs, contract research organizations (CROs), and other external partners to ensure compliance with timelines, budgets, and quality standards.
Supervise and manage electronic data capture (EDC) systems and electronic trial master file (eTMF) platforms.
Collaborate with Regulatory Affairs, Quality Assurance, Biostatistics, and Program Management teams to ensure protocol compliance and clinical integrity.
Provide clinical insights in core team meetings and contribute to strategic decision-making.
Support regulatory submissions with clinical documentation and respond to regulatory agency queries.
Identify, evaluate, and mitigate risks across the clinical trial lifecycle.
Mentor junior clinical staff and contribute to process improvement initiatives.
Required Qualifications:
Bachelor’s degree in Life Sciences or related field; advanced degree (MS, MPH, PhD) preferred.
Minimum 2 years of experience in clinical trial management, preferably in diagnostics or medical devices.
Knowledge of FDA regulations including 21 CFR Part 812, 50, and 11.
Experience with 510(k) and CLIA waiver regulatory pathways.
Proven experience managing multi-site clinical trials and collaborating with CROs and external vendors.
Proficiency in clinical trial systems such as EDC and eTMF.
Preferred Qualifications:
2+ years of experience with IRB submissions for in-vitro diagnostics.
Scientific laboratory or clinical research experience.
Strong organizational, leadership, and communication skills.
Ability to work independently and collaboratively in a fast-paced, cross-functional environment.
Why Abbott:
Competitive compensation with base pay ranging from $90,000 – $180,000.
Comprehensive health, wellness, and retirement benefits.
Career development and tuition assistance programs.
Opportunities to work with innovative diagnostic solutions impacting patient care globally.
Apply Now:
Advance your career as a Clinical Trial Manager at Abbott, leading critical clinical research that supports medical innovations and improves patient outcomes worldwide.
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