Medical and Clinical Affairs United States - California -
Abbott is a global healthcare leader that helps people live more
fully at all stages of life. Our portfolio of life-changing
technologies spans the spectrum of healthcare, with leading
businesses and products in diagnostics, medical devices,
nutritionals and branded generic medicines. Our 103,000 colleagues
serve people in more than 160 countries.
For years, Abbott’s medical device businesses have offered
technologies that are faster, more effective, and less invasive.
Whether it’s glucose monitoring systems, innovative therapies for
treating heart disease, or products that help people with chronic
pain or movement disorders, our medical device technologies are
designed to help people live their lives better and healthier.
Every day, our technologies help more than 10,000 people have
healthier hearts, improve quality of life for thousands of people
living with chronic pain and movement disorders, and liberate more
than 500,000 people with diabetes from routine ?ngersticks.
Our location in Sacramento, CA and Bay Area
Regions, currently has an opportunity for a Clinical Site
Lead . The Clinical Site Lead drives study execution and
operational excellence across Abbott Cardiovascular therapies
(Vascular, Cardiac Rhythm Management, EP, Structural Heart, and
Heart Failure). Recognized resource in protocol execution,
increasing product and disease state knowledge, procedure support
(as needed), procedure outcomes and early indication of trends,
clinical trial enrollment, and ICH-GCP and clinical research
Adheres to specified site nomination, qualification, and startup
processes. Leads ongoing training/retraining of all site
stakeholders to ensure protocol adherence. Continuously reviews,
manages, and influences all aspects of site’s recruitment and data
collection performance (enrollment, discrepancy resolution,
compliance, etc.). Proactively utilizes appropriate operational
metrics to minimize screen failure, attrition rate, etc. Monitors
to ensure compliance with applicable regulatory requirements, Good
Clinical Practice, and accuracy standards inclusive of site
initiation, periodic, and close-out visits.
May be consulted in the following areas: study design, site
payments, site audits, local document review, study documents
preparation, and submission to site or competent authority/ethics
WHAT YOU’LL DO
With limited direction from leadership:
Develop and maintain a productive clinical territory:
Identify, develop, and maintain sites capable of delivering
start-up goals, study participation levels and required data
Understand and assess investigators’ interests and
Identify appropriate investigators as defined by study-specific
requirements and by the applicable regulatory code.
Maintain open communication and relationships with key site
personnel including the Principle Investigator, Research
Coordinator, as well as regulatory and legal personnel.
Provide ongoing technical support to customers and field
Facilitate communication between clinical sites and other Abbott
clinical staff (e.g., operations management, study team, Site
Contracts Associate), as needed.
Manage all aspects of study lifecycle to include site regulatory
Start Up Nominate, approach, and complete qualification
processes including establishing site/sponsor expectations for
Facilitate all aspects of the start-up process and site
Understand regulatory and legal requirements for study
participation at a level that allows for appropriate collaboration
with Abbott clinical staff, e.g. Site CRA, Site Contract
Train facility staff regarding protocol requirements and
Develop site-specific strategies to promote appropriate patient
Identify site successes and challenges and assist in
implementing techniques that promote study goal achievement.
Continuously evaluate site study performance and provide timely
feedback to site.
Attend study procedures and follow-ups when indicated (or ensure
trained personnel attend).
Regulatory and Quality Core level Abbott certification and/or
equivalent level proficiency
Develop site-specific strategies to avoid deviations.
Educate site on tools to facilitate compliance.
Provide timely feedback to the sites on key compliance
Escalate non-compliant sites according to corporate policy.
Collect essential documents, identify and obtain missing data,
data corrections, reviewing adverse events and protocol
Review data and source documentation from investigational sites
for accuracy and completeness
Facilitate resolution of data queries and action items at
Promptly reports the findings of monitoring visits according to
Maintain accurate, detailed and complete records of monitoring
Provide training and procedure coverage:
Apply clinical and technical expertise to train site and Abbott
staff for clinical trials and applicable commercial launches.
As needed, provide clinical and technical expertise for clinical
trial procedure support
Attend study procedures and follow-ups (or ensure trained
Collaborate with commercial partners:
When appropriate, collaborate in the education of local sales
groups on new product launches.
When appropriate, contribute to the education of customers on
new and existing Abbott products.
Meet with key customers where Abbott GCO presence can elevate
the customer experience.
Act as an additional resource for technical questions and
Identify and adapt to shifting priorities and competing demands.
Remain current on developments in the field of expertise including
clinical and Abbott product knowledge, competitive positioning and
published scientific and economic evidence.
Maintain at least one area of expertise and function as a local
clinical and technical resource.
Develop working knowledge of disease states and product lines
for all relevant Abbott clinical trials.
Upon leadership approval, complete and maintain certifications
that are relevant to specific field(s) of expertise (where
Possess independent problem-solving skills and ability to make
decisions. Exhibit excellent oral and written communication
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelor’s Degree in engineering, biological sciences, nursing,
equivalent or related certification in CRM.
Advanced Practice Providers preferred.
Strong background with sponsor required require responsibilities
in clinical trials.
Strong regulation background within clinical trials.
Two years of progressively more responsible relevant clinical
trial experience in the cardiovascular field.
Competency in catheterizaion lab and operating room protocol and
Ability to travel approximately 50%, including
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great
career. We offer:
Training and career development , with onboarding programs for
new employees and tuition assistance
Financial security through competitive compensation,
incentives and retirement plans
Health care and well-being programs including medical,
dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company
The stability of a company with a record of strong
financial performance and history of being actively involved
in local communities
Follow your career aspirations to Abbott for diverse
opportunities with a company that provides the growth and strength
to build your future. Abbott is an Equal Opportunity Employer,
committed to employee diversity.
Get tailored job recommendations based on your interests. JOB
LOCATION United States - California - Remote
DIVISION MD Medical Devices
TRAVEL Yes, 75 % of the Time
MEDICAL SURVEILLANCE Not Applicable
SIGNIFICANT WORK ACTIVITIES Continuous sitting for prolonged
periods (more than 2 consecutive hours in an 8 hour day)
Continuous standing for prolonged periods (more than 2
consecutive hours in an 8 hour day)
Driving a personal auto or company car or truck, or a powered
piece of material handling equipment
Keyboard use (greater or equal to 50% of the workday)
Our business encompasses many different functions and
capabilities, which allows you to explore careers in various
GROWTH PLANNING Growth Planning and Performance Excellence is an
annual process through which you'll be able to have open career
discussions with your manager to help you determine your own career
path and future.
TRAINING & NETWORKS We provide a wide range of classroom and
e-learning courses to help you develop new skills and enhance your
WE'RE RECOGNIZED AROUND THE WORLD DOW JONES SUSTAINABILITY INDEX
BEST CORPORATE CITIZENS FORTUNE CHANGE ???????THE WORLD FORTUNE'S
MOST ADMIRED COMPANIES JOIN OUR TALENT COMMUNITY We will notify you
about relevant positions, and keep you in mind whenever we have
Abbott welcomes and encourages diversity in our workforce
including Minorities, Women, Individuals with Disabilities and
Protected Veterans. We provide reasonable accommodation to
qualified individuals with disabilities.
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appearing in this Internet site are trademarks owned by or licensed
to Abbott, its subsidiaries or affiliates. No use of any Abbott
trademark, trade name, or trade dress in this site may be made
without the prior written authorization of Abbott, except to
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