Clinical Trial Manager

Abbott Laboratories • San Diego, CA

3d • Onsite

About The Position

The Clinical Trial Manager works out of our San Diego, CA office location in the Infectious Disease Division in Abbott Rapid Diagnostics. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers. The person hired will be considered an expert for clinical trial design of rapid in-vitro diagnostics for 510(k) OTC and dual 510(k) and CLIA waiver regulatory pathways. They will work closely with cross-functional teams and participating on the core team.

Requirements

• Bachelor’s degree in life sciences or related field; advanced degree (e.g., MS, MPH, PhD) preferred.
• Minimum of 2 years of experience in clinical trial management, preferably in diagnostics or medical devices.
• Strong knowledge of FDA regulations, including 21 CFR Part 812, 50, and 11, and experience with 510(k) and CLIA waiver pathways.
• Proven track record in managing multi-site clinical trials and working with CROs and external vendors.
• Proficiency with clinical trial systems such as EDC and eTMF.
• 10% Travel for the role

Nice To Haves

• 2 + years of experience with IRB submissions for In vitro diagnostics and regulatory submission pathways for 510(k) OTC and dual 510(k) and CLIA waiver pathways
• Minimum of 2 years' experience in conducting clinical research or related scientific laboratory skills.
• Excellent organizational, communication, and leadership skills.
• Ability to work independently and collaboratively in a fast-paced, cross-functional environment.

Responsibilities

• Oversee clinical protocol development and review to meet required targets.
• Start up the enrollment and close out activities for clinical sites, reference lab, CRO and other management. Supervision and management of EDC and eTMF.
• Lead the development, review, and finalization of clinical protocols to meet regulatory and scientific objectives.
• Manage all aspects of clinical trial operations including study start-up, site initiation, patient enrollment, monitoring, and study close-out.
• Oversee clinical site activities, reference laboratories, 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 to ensure data integrity and regulatory compliance.
• Collaborate closely with cross-functional teams including Regulatory Affairs, Quality Assurance, Biostatistics, and Program Management.
• Participate in core team meetings to provide clinical insights and contribute to strategic decision-making.
• Ensure adherence to Good Clinical Practice (GCP), applicable regulatory requirements, and internal SOPs.
• Support regulatory submissions by providing clinical documentation and contributing to responses to regulatory agencies.
• Identify and mitigate risks throughout the clinical trial lifecycle.
• Mentor and guide junior clinical staff and contribute to continuous process improvement initiatives.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees