Manager, Clinical Affairs Specimen Operations

Minimum Qualifications

• Bachelor’s Degree in health or life sciences, Engineering, Information Technology, Management Information Systems, or a related discipline.

• 8+ years of project management experience with increasing responsibility of scope and leadership.

• 5+ years managing and leading large impact, large budget, high-risk, client-facing, and critical projects using Project Management software.

• 2+ years of experience managing direct reports or project team members in a clinical research environment in a healthcare or clinical research environment.

• Experience with specimen management, clinical research studies, and/or lab specimen management preferred.

• Experience in start-up clinical research studies for specimen logistics.

• Authorization to work in the United States without sponsorship.

• Demonstrated ability to perform the position's Essential Duties with or without accommodation.

• Lead relationships and communication and liaise with cross functional team members involved in specimen logistics, Clinical IT, Clinical Supply, and Clinical Lab, but not limited to these
• Process engineer and design strategy for clinical research study specimen logistics and other specimen collection types needed per defined programs.
• Identifying specimen logistic improvements through workflow analysis.
• Evaluate and conduct research to develop new and improve processes for specimen logistics for existing and new projects of varying complexities.
• Define, report, and improve the metrics and tracking that feed overall workflow and process performance to make decisions on usable specimens/subjects, kit projections, and advancement of the forecasting process that is required to support study logistics.
• Assess cross-functional impact and integrate stakeholder recommendations/needs to streamline process flow.
• Perform technical analysis to understand and reduce risk, establish the timeline for cross-functional stakeholder readiness.

• Excellent leadership, planning, prioritization, and project management ability; exhibiting effective decision making, problem-solving skills, and interpersonal skills; influence and persuade and is results-oriented.

• Ability to exercise judgment and determine appropriate action to a variety of problems of varying complexity.

• Ability to make critical decisions based upon a combination of data analysis, experience, and judgement.

• Ability to balance multiple competing priorities within and across multiple projects.

• Adaptable to rapid changes in priorities, strong sense of urgency, and able to identify ways to work together to achieve results needed for all requests.

• Apply excellent oral and written communication and presentation skills; detail-oriented.

• Identify strategic initiatives with leadership, identify resources, and timelines.
• Assist teams with breaking project work into manageable packages and organizing it into a project schedule.
• Develop schedules, budget planning, forecasting, reporting, and partners with designated financial analyst as needed, risk management plans, and lead the team to success.

• Recruit, train, and support team members for various positions.

• Provide performance feedback and initiate career development discussions and planning for all direct reports.

• Work with leadership on resource planning, FTE and headcount allocation, and strategic direction of organization as appropriate.

• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.

• Support and comply with the company’s Quality Management System policies and procedures.

• Ability to lift up to 10 pounds for approximately 5% of a typical working day.

• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.

• Ability to travel up to 10% of the working time away from the work location, between local Abbott Cancer Diagnostics locations, which may include overnight/weekend travel.