Clinical Project Manager, Cellcolabs AB

at  Cellcolabs

Are you a forward-thinking, goal- and service-oriented person with significant experience of project management or clinical monitoring of clinical trials according to ICH-GCP?
Are you interested in joining an entrepreneurial environment and grow rapidly with a company where you can make a real difference to patients’ lives? Then this role as Clinical Project Manager at Cellcolabs could be your next career move!

ABOUT CELLCOLABS

Cellcolabs is an impact start-up specializing in the industrial GMP production of high-quality Mesenchymal Stromal Cells (MSCs). Our mission is to prevent and treat diseases by making high quality stem cells available and affordable. We do that by industrial scale production and collaborations. Based at Campus Solna, Cellcolabs builds on over 20 years of stem cell research and clinical expertise from Karolinska Institutet.
We are expanding through a series of clinical trials across different locations and are seeking a dedicated Project Manager to ensure the generation of high-quality, ICH-GCP compliant data in these trials.

QUALIFICATIONS AND REQUIREMENTS

We want you to grow together with us and we will do our best for you to develop and enjoy work. For this role you will need the following:

• A minimum of 3-5 years of experience of clinical trial management either as a clinical project manager or CRA/clinical monitor with expanded responsibilities.
• Proven experience in leading clinical trial teams.
• Strong knowledge of ICH-GCP and practical experience in the pharmaceutical/CRO industry.
• University degree in a life sciences discipline.
• Strong communication skills and excellent skills in written and spoken English
• Willingness and ability to travel internationally.
• Ability to work independently in a fast-paced and evolving environment.
• Exceptional flexibility and prioritization skills.

The role will involve collaboration and teamwork as well as independent work with our partners and team members. The role may involve international travel, with our offices in Solna, Sweden, as the base.

THE ROLE

As a member of our Clinical Success team, you will lead and oversee the planning and execution of our clinical trial projects. Your primary responsibility will be to ensure that our trials are conducted efficiently and are fully compliant with ICH-GCP and our internal Clinical Quality Management System.

KEY RESPONSIBILITIES:

• Manage clinical trials from initiation to close-out, focusing on generating long-term follow-up data in line with study protocols and quality standards.
• Conduct co-monitoring visits and oversee remote monitoring conducted by our clinical monitors at clinical sites.
• Build and maintain effective relationships with internal and external stakeholders to ensure compliance with ICH-GCP and trial protocols.
• Train study sites and the Clinical Success team on study protocols, procedures, ICH-GCP standards, and related topics.
• Ensure all trials are conducted and documented according to the Cellcolabs Clinical Quality Management System and maintain the Trial Master File.
• Collaborate closely within the Clinical Success team and across other functions to enhance clinical trial processes.

We want you to grow together with us and we will do our best for you to develop and enjoy work. For this role you will need the following:

• A minimum of 3-5 years of experience of clinical trial management either as a clinical project manager or CRA/clinical monitor with expanded responsibilities.
• Proven experience in leading clinical trial teams.
• Strong knowledge of ICH-GCP and practical experience in the pharmaceutical/CRO industry.
• University degree in a life sciences discipline.
• Strong communication skills and excellent skills in written and spoken English
• Willingness and ability to travel internationally.
• Ability to work independently in a fast-paced and evolving environment.
• Exceptional flexibility and prioritization skills