Clinical Trial Manager

JOB DESCRIPTION:

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors 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.

The Opportunity

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.

What Youll Work On

• Serve as the clinical trial subject matter expert for rapid in vitro diagnostic studies with a focus on 510(k) OTC and dual 510(k)/CLIA waiver submissions.

• Serve as the clinical trial subject matter expert for rapid in vitro diagnostic studies with a focus on 510(k) OTC and dual 510(k)/CLIA waiver submissions.

• 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.

Required Qualifications:

• Bachelors 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.

• Excellent organizational communication and leadership skills.

• Ability to work independently and collaboratively in a fast-paced cross-functional environment.

Preferred Qualifications:

• 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.

Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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Manager