Associate Project Manager (Set-Up) - Hybrid

CellCarta•Naperville, IL

2d•$70,000 - $80,000•Hybrid

About The Position

CellCarta is seeking an Associate Project Manager to coordinate clinical study set-up activities and support the delivery of clinical research projects. The role is responsible for delivering clinical projects within agreed scope, timeline, and budget by coordinating work performed by internal and external partners, while ensuring compliance with CellCarta’s Quality System. The APM works alongside experienced Project Managers, learning project management methodologies and taking on increasing responsibility over time. The position focuses on study set-up from project award through completion of set-up activities and readiness for study initiation. The APM helps translate study requirements into operational plans and ensures the appropriate teams, documentation, systems, and processes are ready to support the study. When applicable, the APM coordinates an organized handoff to the Project Manager responsible for Study Conduct. The position involves customer engagement, cross-functional coordination, managing multiple priorities and deadlines, proactively identifying needs and risks, communicating with stakeholders, and learning new processes, systems, scientific concepts, and regulatory requirements. The role is based in Naperville, Illinois, and follows a Monday–Friday schedule of 8:00 a.m. to 5:00 p.m., with flexibility. It offers hybrid work arrangements, beginning at approximately one to two work-from-home days per week and gradually increasing 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 ability to multitask and balance multiple priorities.
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, with positive feedback.

Nice To Haves

Study Start-up experience.
Master’s degree in Biology, Biochemistry, Biomedical Sciences, Pharmaceutical Sciences, or Medicine.
Experience in cancer research 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 working 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 after 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 in collaboration 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 the 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 scope changes 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.
Proactively identify and timely escalate set-up risks, issues, dependencies, and roadblocks.
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 after set-up, when applicable.
Coordinate tasks performed by internal and external partners to deliver projects within agreed scope, timeline, and budget.
Ensure study execution and set-up activities comply with CellCarta’s Quality System.