Abbott

Clinical Affairs Specimen Operations Specialist

Abbott • $61K — $122K *
Madison, WI 53711In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in health/life sciences or equivalent experience.
  • 5+ years in a Clinical, IT, or Regulatory role.
  • 3+ years in project management support.
  • Strong proficiency in Microsoft Office tools.
  • Authorization to work in the U.S. without sponsorship.

Responsibilities

  • Develop operational relationships across various teams.
  • Lead small to medium-sized projects and components of larger programs.
  • Coordinate supply and sample management for clinical studies.
  • Liaise with internal and external stakeholders.
  • Provide updates to stakeholders and team members.
  • Support process improvements within clinical and regulatory affairs.
  • Analyze user needs to identify efficiencies and gaps.

Benefits

  • Opportunity to support meaningful work in cancer diagnostics.
  • Collaboration with cross-functional teams for broad exposure.
  • Hands-on role in project and process management.
  • Work in a company dedicated to innovation in healthcare.
  • Contribute to improving clinical study outcomes.
Full Job Description
JOB DESCRIPTION:

The Clinical Affairs Specimen Operations (CASO) Specialist works with cross functional support teams and key stakeholders to support the logistical stand up of all clinical studies and ensure that supply and sample management needs meet the study design requirements. This role will facilitate the project milestone development, facilitate teams to execute and communicate to the broader organization. The CASO Specialist supports the clinical study portfolio for Abbott Cancer Diagnostics commercial and pipeline products, collaborating with Product Core Teams and their respective working groups to successfully meet the development, evidence generation and overall strategic needs of each Abbott Cancer Diagnostics product.

This position is based in our Madison, WI office location.

Essential Duties

Include, but are not limited to, the following:
  • Develop operational relationships with cross functional team members including but not limited to Clinical Laboratories, Regulatory Affairs, Research and Development, Program Management, Biorepository and others as appropriate.
  • Lead defined small and medium-sized projects and components of large projects/programs.
  • Coordinate all activities required for supply and sample management set up for internal and external clinical studies.
  • Liaise between internal and external stakeholders and Abbott Cancer Diagnostics team members.
  • Coordinate and provide communication updates to key stakeholders, management, and team members.
  • Lead and support process improvement initiatives within clinical and regulatory affairs.
  • Analyze systems user needs to identify and communicate efficiencies/gaps cross-functionally.
  • Assess cross-functional impact and integrate stakeholder recommendations/needs to streamline process flow.
  • Visualize and document processes.
  • Define and report on metrics that are indications of the health of the day-to-day sample and data elements supporting clinical studies.
  • Improve the metrics and tracking that feed overall study performance to make decisions on usable samples/subjects, enrollment projections, and advancement of the forecasting process that is required to support study logistics.
  • Assist teams with breaking project work into manageable packages and organizing into a project schedule.
  • Keep related information organized and available to appropriate stakeholders and team members.
  • Manage issues and action items by collaborating directly with team members to ensure completion.
  • Maintain positive working relationships with various internal parties and stakeholders.
  • Assign tasks and confirm completion.
  • Ensure on-time delivery of all assigned goals.
  • Schedule meetings and prepare agenda and minutes at the direction of stakeholders and collaborators.
  • Strong attention to detail.
  • Ability to organize, present, and convey problems or issues.
  • Manage multiple priorities for various stakeholders in a cross-functional matrix environment.
  • Adaptable to rapid changes in priorities, strong sense of urgency, and able to identify ways to work together to achieve results needed for all requests.
  • Strong verbal and written communication skills.
  • Effective presentation skills.
  • Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.
  • Analytical, problem solving and decision-making skills.
  • Ability to coordinate multiple tasks both owned individually and by others.
  • Support and comply with the company's Quality Management System policies and procedures.
  • Maintain regular and reliable attendance.
  • Ability to act with an inclusion mindset and model these behaviors for the organization.
  • Ability to lift up to 10 pounds for approximately 5% of a typical working day.
  • Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
  • Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
  • Ability to work on a computer and phone simultaneously.
  • Ability to comply with any applicable personal protective equipment requirements.
  • Ability and means to travel between local Exact Sciences locations.
  • Ability to travel 10% of working time away from work location, may include overnight/weekend travel.


Minimum Qualifications
  • Bachelor's degree in the health or life sciences, or a field as outlined in the essential duties, or Associate's degree in the health or life sciences and 2 years of experience in a field as outlined in the essential duties in lieu of Bachelor's degree, or High School Degree/General Education Diploma and 4 years of experience in a field as outlined in the essential duties in lieu of Bachelor's degree.
  • 5+ years of experience in a Clinical, IT, or Regulatory role, or a field as outlined in the essential duties.
  • 3+ years of experience in a project management support role.
  • Strong proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook.
  • Authorization to work in the United States without sponsorship.
  • Demonstrated ability to perform the Essential Duties of the position with or without accommodation.


Preferred Qualifications
  • 2+ years of experience in process and workflow design, and process improvement.
  • Certified Associate in Project Management (CAPM) through PMI.
  • Strong understanding of FDA regulations and ICH GCP. Understands global regulations.
  • Good understanding of clinical systems functionality and requirements.


The base pay for this position is
$61,300.00 - $122,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Supply Chain

DIVISION:
ONCO Cancer Diagnostics

LOCATION:
United States > Madison : 5505 Endeavor Ln

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 10 % of the Time

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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