Clinical Affairs Specimen Operations Specialist

Abbott; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

Abbott is seeking a Clinical Affairs Specimen Operations Specialist (CASO) to support the logistical stand up of clinical studies, ensuring supply and sample management meet study design requirements. The role partners with cross-functional teams and stakeholders to drive milestones from startup to closeout, with onsite presence required.

The candidate will translate complex study needs into executable specimen management plans, build alignment across teams, anticipate risks, and communicate

Qualifications

• Develop operational relationships with cross-functional team members (Clinical Laboratories, Regulatory Affairs, R&D, PM, Biorepository, and others).
• Lead defined small and medium-sized projects and components of large projects/programs.
• Coordinate 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.

Responsibilities

• 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 efficiencies and gaps cross-functionally.
• Assess cross-functional impact and integrate stakeholder recommendations to streamline process flow.
• Visualize and document processes.
• Define and report on metrics that indicate the health of 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.

Job description

Position Overview

The Clinical Affairs Specimen Operations Specialist (CASO) 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.The ideal candidate is a proactive, highly organized clinical operations professional who combines strong project management acumen with sound judgment, ownership, and operational excellence. They translate complex study requirements into executable specimen management plans, build cross-functional alignment, anticipate risks and downstream impacts, and communicate effectively to keep stakeholders informed. This individual manages day-to-day execution while proactively resolving issues, improving processes, and delivering study objectives from startup through closeout.

This position is onsite.

Essential Duties

• 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 w