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Clinical Trial Specialist

  • Anywhere

Company :
ALERE

Location :
San Diego, California

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

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Description :
Clinical Trial Specialist
["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
Full-time