Associate Project Manager (Set-Up) - Hybrid

CellCarta•Naperville, IL

1d•Hybrid

About The Position

CellCarta is seeking a highly motivated Associate Project Manager (APM) to coordinate clinical study set-up and support the delivery of clinical research projects. The role is responsible for delivering projects within agreed scope, timeline, and budget, primarily by coordinating tasks performed by internal and external partners and ensuring compliance with CellCarta's Quality System. Working alongside experienced Project Managers, the APM will learn project management methodologies and take on increasing responsibility. Focused on Study Set-Up, the role begins after a project is awarded and continues through completion of set-up activities and readiness for study initiation. When applicable, the APM coordinates a handoff to the Project Manager responsible for Study Conduct. The position involves understanding client needs, coordinating across departments, and keeping projects on task, on track, and on time. The role is based in Naperville, Illinois, with a hybrid arrangement that begins at approximately one to two work-from-home days per week and may increase after the training period.

Requirements

Bachelor's degree in Biology, Biochemistry, Biomedical Sciences, Pharmaceutical Sciences, or Medicine.
1 to 2 years of project coordination, project management, clinical research, laboratory, or related project support experience.
Professional-level communication skills and proficiency in written and spoken English.
Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Power BI.
Excellent organizational skills and the ability to multitask.
Self-motivated, adaptable, and able to thrive in a dynamic environment.
Diligence and strong attention to detail.
Ability to work independently and collaboratively.
Strong critical-thinking and problem-solving abilities.
Customer- and project-service-oriented mindset.
Solution-driven attitude with persistence and determination.
Curiosity, eagerness to learn, humility, teachability, and a positive, energetic attitude.
Demonstrated success managing complex projects to completion, receiving positive feedback, and balancing multiple priorities effectively.

Nice To Haves

Study Start-up experience.
Master's degree in Biology, Biochemistry, Biomedical Sciences, Pharmaceutical Sciences, or Medicine.
Cancer research experience and understanding of clinical laboratories, assay and instrument principles involved in in vitro diagnostic product design and use, and the scientific, statistical, regulatory, and compliance requirements of clinical research.
Experience working in or with Histopathology and/or Genomics services.
Experience in CAP, CLIA, and GCP environments, with working knowledge of EMEA and/or FDA guidelines related to clinical trials.
Experience with histopathology, anatomic pathology, immunohistochemistry (IHC), genomics, FISH, ISH, or immunofluorescence.
Experience in data programming and validation.
Experience working in global settings.

Responsibilities

Initiate study set-up following project award by engaging the appropriate Business Development colleague and/or client, initially with support from an experienced Project Manager.
Draft and develop the analytical plan with the client and internal teams.
Coordinate study set-up activities from project award through study initiation and operational readiness.
Gather study requirements and translate them into set-up activities, timelines, documentation, and internal deliverables.
Coordinate with internal stakeholders to ensure Operations is prepared to initiate study testing, when applicable.
Initiate database builds when required and ensure they begin in a timely manner.
Support preparation and submission of regulatory documentation to ethics committees and regulatory authorities, when required.
Coordinate and host client kick-off meetings, with appropriate support during training and development.
Manage changes in scope during contracting and study set-up, with appropriate supervision.
Maintain comprehensive, up-to-date study set-up documentation, centralized project communications, and detailed meeting minutes.
Identify and escalate set-up risks, issues, dependencies, and roadblocks proactively and promptly.
Maintain professional, customer-focused communication and provide clear set-up updates to internal and external stakeholders.
Coordinate an organized handoff to the Conduct Project Manager upon completion of set-up, when applicable.
Coordinate multiple priorities and deadlines, communicate across internal departments and external stakeholders, and proactively identify actions needed to keep study set-up moving forward.