Manager, Clinical Affairs Specimen Operations

Abbott•Madison, WI

About The Position

The Manager, Clinical Affairs Specimen Operations (CASO) helps deliver solutions that support the organization’s vision and strategic direction. As part of the CASO Leadership Team, this role manages staff and department activities and leads large, complex, high-risk, high-visibility projects across the organization. It ensures integration and communication among projects and collaborates closely with teams at all levels of Abbott Cancer Diagnostics. The role leads cross-functional teams and stakeholders in arranging the logistical setup of clinical studies and ensuring supply and specimen-management needs meet study-design requirements. It facilitates program milestone development and execution, and communicates progress to the broader organization. The manager 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.

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 scope and leadership responsibility.
At least 5 years managing and leading large-impact, large-budget, high-risk, client-facing, 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 between local Abbott Cancer Diagnostics locations and potentially overnight or on weekends.

Nice To Haves

Experience with specimen management, clinical research studies, and/or laboratory specimen management.
Experience setting up 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 with cross-functional colleagues involved in specimen logistics, Clinical IT, Clinical Supply, Clinical Lab, and related functions.
Engineer processes and develop strategies for clinical-study specimen logistics and other specimen-collection requirements.
Identify improvements to specimen logistics through workflow analysis; research, develop, and improve processes for projects of varying complexity.
Define, report, and improve workflow and process-performance metrics used to inform usable specimen and subject decisions, kit projections, and forecasting.
Assess cross-functional impacts and integrate stakeholder recommendations and needs to streamline process flow.
Conduct technical analysis to understand and reduce risk and establish timelines for cross-functional stakeholder readiness.
Identify strategic initiatives with leadership, 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 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.
Uphold company mission and values, and comply with the company’s Quality Management System policies and procedures.