Manager, Clinical Affairs Specimen Operations

Abbott•Madison, WI

2d•$99,300 - $198,700•Onsite

About The Position

The Manager, Clinical Affairs Specimen Operations (CASO) supports Abbott Cancer Diagnostics’ vision and strategic direction as a member of the CASO Leadership Team. The role manages staff, plans and evaluates department activities, and leads large, complex, high-risk, high-visibility projects that affect multiple users across the organization. It requires hands-on collaboration across all levels of Abbott Cancer Diagnostics and coordination and communication among multiple projects. The manager leads cross-functional support teams and stakeholders responsible for the logistical setup of clinical studies, ensuring supply and specimen management meet study design requirements. The role facilitates program milestone development and execution, and supports the clinical study portfolio for commercial and pipeline products in collaboration with Product Core Teams and their working groups. The position is based in Madison, Wisconsin, and requires travel up to 10% of working time, including travel 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 in 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.
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 use a mobile device, tablet, or computer and/or type for approximately 90% of a typical working day.
Ability to travel up to 10% of working time, including travel between local Abbott Cancer Diagnostics locations and possibly overnight or on weekends.
Demonstrated leadership, planning, prioritization, project management, decision-making, problem-solving, interpersonal, influencing, and persuasion skills; results-oriented.
Ability to exercise judgment, choose appropriate actions for problems of varying complexity, and make critical decisions using data analysis, experience, and judgment.
Ability to balance competing priorities across projects, adapt to rapidly changing priorities, act with urgency, and collaborate to achieve results.
Strong 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 involving 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 with cross-functional team members involved in specimen logistics, Clinical IT, Clinical Supply, Clinical Lab, and other relevant areas.
Engineer processes and develop strategies for clinical research study specimen logistics and other specimen collection types required by programs.
Identify specimen logistics improvements through workflow analysis.
Research, develop, and improve specimen logistics processes for existing and new projects of varying complexity.
Define, report, and improve metrics and tracking for workflow and process performance, supporting decisions about usable specimens and subjects, kit projections, and forecasting.
Assess cross-functional impacts and integrate stakeholder recommendations and needs to streamline processes.
Conduct 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 it into project schedules.
Develop schedules, budget plans, forecasts, reports, and risk management plans, partnering with the designated financial analyst as needed, and lead teams toward successful outcomes.
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 and comply with company Quality Management System policies and procedures, and uphold company values of accountability, innovation, integrity, quality, and teamwork.