Clinical Project Manager

Clinical Project Manager

CellCarta

Wilrijk or Antwerp, Belgium

Summary

As a Clinical Project Manager (CPM), you will drive and manage projects with internal stakeholders and external customers (pharma and biotech partners in oncology) to deliver results on time, in full, and in alignment with the CellCarta Quality System.

As a CPM, you will gain a comprehensive understanding of the entire business model and will often be the first to identify what our customers need. As a CPM, you are ultimately responsible for embodying the 3 T’s: keeping the project on Task, on Track, and on Time.

You will need to be comfortable doing the following:

• Listening actively to the customer and building relationships to ensure client satisfaction;
• Managing yourself effectively under pressure;
• Prioritizing being effective over being right;
• Being open and willing to transform yourself;
• If you are organized, analytically minded, possess a solid technical background, and thrive in a dynamic, high-complexity environment, this might just be the role you’re looking for!

Responsibilities

The CPM is responsible for the delivery of clinical projects within the agreed scope, time, and budget - primarily by coordinating a multitude of tasks performed by internal and external partners. The CPM ensures that each project is executed in compliance with CellCarta’s Quality System. Their responsibilities begin when a clinical project is awarded to CellCarta and conclude once the project is delivered to the sponsor, the study is properly archived, and final invoicing is prepared.

More specifically, you will participate in the following:

• Manage clinical studies from initiation through close-out and archiving, including reporting, in compliance with GCP guidelines and regulations;
• Review all essential documents required for study initiation and ensure audit-ready study files are maintained throughout the duration of the study;
• Prepare and/or approve sample flow designs, study trackers, bioanalytical reports, and other required documentation for clinical studies;
• Monitor and control the study budget;
• Maintain and document professional communication with the sponsor, cross-functional project team, and management throughout the study;
• Chair sponsor calls.

Education

• A Master’s degree in Sciences, Biomedical Sciences, Pharmaceutical Sciences, Medical Biology, Medicine, or equivalent expertise gained through experience.

Main Requirements

• 2+ years of project management and/or CRA (Clinical Research Associate) experience, or a background working in histotechnology laboratories;
• A strong curiosity and eagerness to learn, paired with a humble and teachable attitude;
• Proven success in managing complex projects to completion, with positive feedback and the ability to balance multiple priorities effectively;
• Professional-level communication skills; proficient in English, both written and verbal;
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Power BI);
• Excellent organizational skills with the ability to multitask;
• Positive and energetic attitude;
• Self-motivated, adaptable, and able to thrive in a dynamic environment;
• Diligent with strong attention to detail;
• Capable of working both independently and collaboratively;
• Strong critical thinking and problem-solving abilities;
• Customer- and project service–oriented mindset;
• A solution-driven attitude with persistence and determination.

It's great, but not required, if you have:

• Experience in cancer research, with an understanding of clinical laboratories, assay/instrument principles involved in in vitro diagnostic product design and use, as well as the scientific, statistical, regulatory, and compliance requirements of clinical research;
• Genomics background, with knowledge of key principles, techniques, and platforms;
• Experience working in CAP, CLIA, and GCP environments, with a working knowledge of EMEA and/or FDA guidelines related to clinical trials;
• Experience in data programming and validation;
• Experience working in global settings.

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