Clinical Affairs Specimen Operations Specialist

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 or experience in a project management support role.
• Strong proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, and Outlook.
• Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

• 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.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• 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 Abbott Cancer Diagnostics locations.
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.