Manager, Clinical Affairs Specimen Operations

Abbott•Madison, WI

2d•$99,300 - $198,700

About The Position

The Manager, Clinical Affairs Specimen Operations (CASO) delivers solutions supporting 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, complex, high-risk, high-visibility projects across the organization. The position ensures integration and communication across projects and requires close collaboration with all levels of Abbott Cancer Diagnostics. The Manager leads cross-functional support teams and stakeholders in the logistical setup of clinical studies, ensuring supply and specimen-management needs meet study design requirements. The role facilitates program milestone development, team execution, and communication across the 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 work on time.

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 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 away from the work location, including between local Abbott Cancer Diagnostics locations and potentially overnight or on weekends.
Strong leadership, planning, prioritization, project management, decision-making, problem-solving, interpersonal, influencing, and persuasion skills; results-oriented.
Ability to exercise judgment and determine appropriate actions for problems of varying complexity.
Ability to make critical decisions using data analysis, experience, and judgment.
Ability to balance competing priorities across multiple projects and adapt to rapidly changing priorities 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 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 communications with cross-functional stakeholders involved in specimen logistics, Clinical IT, Clinical Supply, and Clinical Lab.
Engineer processes and design 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 projects of varying complexity.
Define, report, and improve workflow metrics and tracking to inform usable specimen and subject decisions, kit projections, and forecasting for study logistics.
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, including required 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; partner with designated financial analysts 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.
Uphold company mission and values, including accountability, innovation, integrity, quality, and teamwork.
Support and comply with company Quality Management System policies and procedures.