Hybrid Clinical Study Set-Up Coordinator

Are you looking for an exciting new career opportunity? Cell Carta, a Contract Research Organization (CRO), is seeking a highly motivated Associate Project Manager (APM) to join our dynamic team. As an APM, you will have the opportunity to develop your project management expertise while coordinating clinical study set-up activities and supporting the successful delivery of clinical research projects. Join a team of talented professionals committed to making a positive impact on human health and well-being.

As an APM, you will be responsible for the delivery of clinical projects within the agreed scope, timeline, and budget, primarily by coordinating a multitude of tasks performed by internal and external partners. You will ensure that each project is executed in compliance with Cell Carta's Quality System.

You will work alongside a team of experienced Project Managers to learn project management methodologies and gradually assume increasing responsibilities that contribute to project success.

As an APM focused on Study Set-Up, your responsibilities begin once a project has been awarded and continue through the completion of study set-up activities and readiness for study initiation. When applicable, you will coordinate an effective handoff to the Project Manager responsible for Study Conduct.

You will gain a comprehensive understanding of the entire business model and will often be the first to identify our customers' needs. You are ultimately responsible for embodying the 3 T's: keeping projects on Task, on Track, and on Time.

• Listen to customers and build strong relationships to ensure client satisfaction
• Manage multiple priorities and deadlines in a fast-paced environment
• Coordinate activities across multiple internal departments
• Proactively identify what is needed to keep study set-up activities moving forward
• Communicate clearly with internal and external stakeholders
• Manage yourself effectively under pressure
• Take initiative while knowing when to escape risks or roadblocks
• Be willing to learn new processes, systems, scientific concepts, and regulatory requirements
• If you are organized, analytically minded, possess a solid technical background, and thrive in a dynamic, high-complexity environment, this may be the role for you!

You will be responsible for coordinating clinical study set-up activities from project award through study initiation and making relevant updates as study and client needs evolve. Working with experienced Project Managers and cross-functional teams, you will help ensure that study requirements are translated into clear operational plans and that the appropriate teams, documentation, systems, and processes are in place to support the study.

You will ensure that set-up activities are completed in compliance with Cell Carta's Quality System and will support an organized handoff to the Conduct Project Manager, when applicable.

• Initiate study set-up following project award by proactively engaging the appropriate Business Development colleague and/or client, initially with support from an experienced Project Manager
• Draft and develop the analytical plan, the core governing document that defines how a study will be executed, 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 clear 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 are started 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 changes in scope that occur during contracting and study set-up, with appropriate supervision
• Maintain comprehensive and up-to-date study set-up documentation, centralized project communications, and detailed meeting minutes
• Identify and escalated set-up risks, issues, dependencies, and roadblocks in a proactive and timely manner
• Maintain professional, customer-focused communication and provide clear…