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Clinical Trial Specialist

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Company :
Abbott

Location :
San Diego, California

Expiry Date :
Sun, 08 Nov 2020 23:59:59 GMT

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Description :
Clinical Trial Specialist

REQ

NA-USA-California-San Diego

DO WORK THAT MATTERS.
At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. The position of Clinical Affairs Specialist, Competitor Product Test Lab is within our Infectious Disease Developed Markets located at San Diego. In this role you will have minimal supervision, be responsible for the coordination, management and monitoring of analytical or clinical studies undertaken by the company in support of research, marketing/sales, and regulatory objectives. This job requires in-depth experience and capability of competitor product comparison study management.
RESPONSIBILITIES:

– Lead all operational aspects of competitor studies for which he/she is responsible for.

– Participate in site selection and initiation activities, and drive confidentiality agreement, site qualification, budget negotiation and contract.

– Draft protocols for company supported studies with input from technical, regulatory, quality assurance, and marketing personnel and, as appropriate, regulatory agencies.

– Deliver study materials in a timely fashion (e.g., Reagents, Consumables, Instruments, Software, Sample Transport Systems, etc.)

– Actively monitors status of communications with clinical study sites

– Maintains and manage clinical study activities in database systems, consistent with company timelines and objectives

– Constructs and audit data files

– Supports all clinical affairs activities as needed .

– Travel is expected to be around 30%. Travel to sites for study initiation, training and assessment of research study team activities.

– Perform other duties & projects as assigned.

BASIC QUALIFICATIONS:

– Master’s Degree in Chemistry, Biology, or other related Science field.

– 3+ years’ experience in clinical study research and/or in biotechnology or related industry.

– Prior experience managing product performance evaluation studies or within the biotech or device industry. Point-of-care industry experience is a plus.

PREFERRED QUALIFICATIONS:

– In-depth knowledge of infectious disease competitive landscape and products.

– Strong technical background and capable of analyzing product specification, performance aspects and limitations.

– Ability to perform scientific analysis to assess current publications.

COMPETENCIES:

– Drive for results and thrive in a fast paced environment.

– Strong interpersonal skills and ability to interact at all levels with sensitivity and tact.

– Strong organizational skills, with attention to details.

About Abbott.
At Abbott, we’re committed to helping people live their best possible life through the power of health. For more than 125 years, we’ve brought new products and technologies to the world — in nutrition, diagnostics, medical devices and branded generic pharmaceuticals — that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce. We provide reasonable accomodation to qualified individuals with disabilities. To request accomodation, please send an email to .

Clinical / R & D

Research and Development

Full-time