Manager, Clinical Affairs Specimen Operations

Abbott•Madison, WI

About The Position

The Manager, Clinical Affairs Specimen Operations (CASO) delivers solutions that support the organization’s vision and strategic direction. As part of the CASO Leadership Team, this role manages staff, plans and evaluates department activities, and leads large, high-risk, high-visibility, critical projects across the organization. The work involves integrating and communicating across multiple complex projects and collaborating with all levels of Abbott Cancer Diagnostics. The manager leads cross-functional support teams and key stakeholders in the logistical setup of clinical studies, ensuring supply and specimen management needs align with study design requirements. The role facilitates program milestone development, team execution, and communication to the broader organization. It supports the clinical study portfolio for Abbott Cancer Diagnostics commercial and pipeline products, working with Product Core Teams and their working groups to deliver high-quality results on time. The position also develops and improves specimen logistics processes, analyzes workflow and performance metrics, supports forecasting and risk reduction, and coordinates stakeholder readiness. It has people-management responsibilities, including recruiting, training, supporting, and providing performance feedback and career development to direct reports. The role supports company quality policies and values. It requires the ability to lift up to 10 pounds for approximately 5% of a typical workday and to use a mobile device, tablet, or computer and/or type for approximately 90% of a typical workday. Travel of up to 10% is required, including between local Abbott Cancer Diagnostics locations and potentially overnight or weekend travel.

Requirements

Bachelor’s degree in health or life sciences, engineering, information technology, management information systems, or a related discipline.
At least 8 years of project management experience with increasing responsibility for scope and leadership.
At least 5 years managing and leading large-impact, large-budget, high-risk, client-facing, and critical projects using project management software.
At least 2 years managing direct reports or project team members in a clinical research environment in healthcare or clinical research.
Authorization to work in the United States without sponsorship.
Demonstrated ability to perform the position’s essential duties with or without accommodation.
Ability to lift up to 10 pounds for approximately 5% of a typical working day.
Ability to work on a mobile device, tablet, or computer screen and/or type for approximately 90% of a typical working day.
Ability to travel up to 10% of working time, including between local Abbott Cancer Diagnostics locations and potentially overnight or weekend travel.
Strong leadership, planning, prioritization, and project management abilities, including effective decision-making, problem-solving, interpersonal, influencing, and persuasion skills.
Ability to exercise judgment and determine appropriate action for problems of varying complexity, and make critical decisions using data analysis, experience, and judgment.
Ability to balance competing priorities across multiple projects and adapt to rapid priority changes with a strong sense of urgency.
Excellent oral and written communication and presentation skills, with attention to detail.

Nice To Haves

Experience with specimen management, clinical research studies, and/or laboratory specimen management.
Experience starting clinical research studies for specimen logistics.
Master’s degree.
PMI certification.
At least 5 years working with specimen logistics, clinical affairs, regulatory affairs, biorepositories, and/or laboratories.

Responsibilities

Lead relationships and communication among cross-functional team members involved in specimen logistics, Clinical IT, Clinical Supply, Clinical Lab, and other relevant groups.
Engineer and design strategies for specimen logistics and other specimen collection types required by clinical research programs.
Identify specimen logistics improvements through workflow analysis.
Research, develop, and improve specimen logistics processes for projects of varying complexity.
Define, report, and improve metrics and tracking used to assess workflow and process performance, usable specimens and subjects, kit projections, and forecasting for study logistics.
Assess cross-functional impacts and integrate stakeholder recommendations and needs to streamline process flow.
Perform technical analysis to understand and reduce risk and establish timelines for cross-functional stakeholder readiness.
Identify strategic initiatives with leadership and determine resources and timelines.
Help teams break project work into manageable packages and organize the work into project schedules.
Develop schedules, budget plans, forecasts, reports, and risk management plans; partner with a designated financial analyst as needed and lead teams to successful delivery.
Recruit, train, and support team members.
Provide performance feedback and initiate career development discussions and planning for direct reports.
Work with leadership on resource planning, FTE and headcount allocation, and organizational strategic direction as appropriate.
Support Abbott Cancer Diagnostics’ clinical study portfolio for commercial and pipeline products in collaboration with Product Core Teams and working groups.
Support and comply with company Quality Management System policies and procedures and uphold company values.