Manager, Clinical Affairs Specimen Operations
About The Position
The Manager, Clinical Affairs Specimen Operations (CASO) leads teams and projects supporting the logistical setup of clinical studies and ensuring that supply and specimen management meet study design requirements. Working with the CASO Leadership Team, this hands-on role manages department activities and large, complex, high-risk, high-visibility projects across Abbott Cancer Diagnostics. The manager coordinates integration and communication across projects, cross-functional support teams, stakeholders, Product Core Teams, and working groups to deliver high-quality clinical study portfolio outcomes on time for commercial and pipeline products. The position develops and improves specimen logistics processes, evaluates workflows and performance metrics, manages forecasting and readiness, and supports program milestones and schedules. It also includes staff recruitment, training, performance feedback, career development, resource planning, budget planning, and risk management. The role supports the company’s Quality Management System and upholds its mission and values.
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 healthcare or clinical research environment.
- Experience in start-up clinical research studies for specimen logistics.
- Authorization to work in the United States without sponsorship.
- Ability to perform the position’s essential duties with or without accommodation.
- Excellent leadership, planning, prioritization, project management, decision-making, problem-solving, interpersonal, communication, presentation, and organizational skills.
- Ability to exercise judgment, make critical decisions based on data analysis and experience, balance competing priorities, and adapt to changing priorities.
- Ability to influence and persuade, work with urgency, and collaborate to achieve results.
- 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 between local Abbott Cancer Diagnostics locations, potentially including overnight or weekend travel.
Nice To Haves
- Experience with specimen management, clinical research studies, and/or laboratory specimen management.
- Master’s degree.
- PMI certification.
- At least 5 years working with specimen logistics, clinical affairs, regulatory affairs, biorepositories, and/or laboratories.
Responsibilities
- Lead relationships, communication, and coordination among 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 needs.
- 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, including usable specimens and subjects, kit projections, and forecasting.
- Assess cross-functional impacts and incorporate stakeholder recommendations and needs to streamline processes.
- Conduct technical analysis to understand and reduce risk and establish cross-functional stakeholder readiness timelines.
- Identify strategic initiatives with leadership, resources, and timelines.
- Help teams break project work into manageable packages and organize work into project schedules.
- Develop schedules, budget plans, forecasts, reports, and risk management plans, partnering with a designated financial analyst as needed.
- 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.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
