Manager, Clinical Affairs Specimen Operations

Abbott Laboratories; San Diego (CA); On-site; USD 99,000 - 199,000; Full time

Job summary

Abbott is seeking a Manager, Clinical Affairs Specimen Operations (CASO) to lead cross-functional teams coordinating the logistical stand up of clinical studies. You will drive program milestones, manage high-risk projects, and ensure alignment with study design requirements across Abbott Cancer Diagnostics.

You will mentor staff, manage budgets, and collaborate with Product Core Teams to deliver high-quality deliverables on time.

Qualifications

• Bachelor’s degree in health or life sciences, engineering, IT, MIS or related discipline.
• 8+ years of project management experience with increasing responsibility.
• 2+ years managing direct reports or project teams in a clinical research environment.
• Experience with specimen management, clinical research studies, and/or lab specimen management preferred.
• Authorization to work in the United States without sponsorship.

Responsibilities

• Lead relationships and communication with cross functional team members in specimen logistics, Clinical IT, Clinical Supply, and Clinical Lab.
• Process engineer and design strategy for clinical research study specimen logistics and other specimen collection types.
• Identify specimen logistic improvements through workflow analysis.
• Evaluate and conduct research to develop new and improve processes for specimen logistics.
• Define, report, and improve metrics and tracking to inform decisions on specimens, kit projections, and forecasting for study logistics.
• Assess cross-functional impact and integrate stakeholder recommendations to streamline process flow.
• Perform technical analysis to understand and reduce risk, establish timelines for stakeholder readiness.
• Recruit, train, and support team members; provide performance feedback and career development.
• Work with leadership on resource planning, FTE/headcount allocation, and strategic direction.

Skills

Leadership

Project management

Strategic planning

Decision making

Communication

Cross-functional collaboration

Team development

Resource planning

Problem solving

Education

Bachelor’s Degree in health or life sciences, Engineering, IT, MIS, or related

Master’s Degree

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Position Overview

The Manager, Clinical Affairs Specimen Operations (CASO) successfully delivers solutions to support the organization’s vision and strategic direction. The Manager, CASO works as a part of the CASO Leadership Team to accomplish department objectives by managing staff, planning, and evaluating department activities. This role manages and leads large, high risk, high visibility, and critical projects across the Organization. These projects are often highly complex and impact many users. This position ensures successful integration and communication between multiple projects. This is a hands-on role that requires close collaboration with all levels of Abbott Cancer Diagnostics.

The Manager, CASO will focus on leading and managing cross functional support teams and key stakeholders to support the logistical stand up of all clinical studies and ensure that supply and specimen management needs meet the study design requirements. This role will facilitate the program milestone development, facilitate teams to execute and communicate to the broader organization. The Manager supports the clinical study portfolio for Abbott Cancer Diagnostics commercial and pipeline products, collaborating with Product Core Teams and their respective working groups to successfully complete high-quality deliverables on time.

Essential Duties

include but are not limited to the following:

• 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.

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.

Preferred Qualifications

• Master’s Degree

• PMI certification

• 5+ years working with specimen logistics, clinical affairs, regulatory affairs, biorepositories, and/or laboratories

The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.