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 109,000 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 the Michigan Region, currently has an
opportunity for a Senior Clinical Site Lead. The Senior Clinical
Site Lead drives study execution and operational excellence across
Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm
Management, EP, Structural Heart, and Heart Failure). Advanced
subject matter resource in protocol execution, multiple 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 application.
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
committee. Beyond developing and maintaining a productive clinical
territory, the Senior Clinical Site Lead is a recognized leader and
expert that provides support, mentoring and guidance to other
clinical site management colleagues and supports key
projects/initiatives in Global Clinical Operations and/or Business
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
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
Territory Optimization, Expanded Clinical/Technical Expertise,
and Contributions beyond Territory
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, science, health science,
nursing, or a related field, OR equivalent or related experience in
cardiology or clinical research.
- Minimum 5 years : In a clinical research environment. Knowledge
of regulations and standards (Good Clinical Practices) for
conducting clinical research.
- 5 years of progressively more responsible relevant clinical
trial experience in the cardiovascular field; at least three years
of experience as clinical monitor)
- Competency in catheterizaion lab and operating room protocol
- Ability to travel approximately 75%, 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 match
- The stability of a company with a record of strong financial
performance and history of being actively involved in local
Learn more about our benefits that add real value to your life
to help you live fully: www.abbottbenefits.com
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.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and