Overview
We are looking for a Clinical Trial Manager to join our agile team in a permanent, full-time capacity in Belgium or the Netherlands (region of Limburg).
Convert Pharmaceuticals is a dynamic pharmaceutical company aimed at targeting tumor hypoxia, a leading cause of resistance to oncology treatments. Our core mission is to develop products that seek to improve the treatment outcomes and quality of life for people living with cancer. Our company has recently finalized a prestigious EIC Accelerator grant by the European Commission and its lead compound is being investigated in a Phase I–IIa clinical study.
Responsibilities
* Lead the full execution of a Phase I & IIa clinical study in a cost-effective, ethical, and results-oriented way.
* Develop and maintain clinical study timelines and budget within the agreed plan.
* Monitor and provide proactive project updates to internal and external stakeholders in line with site contracts.
* Lead and manage clinical study activities including but not limited to:
o Keeping all study-related documents up-to-date (Protocol, ICFs, IB, …)
o Regulatory and amendment submissions
o Overseeing monitoring and other subcontracted activities
o Make sure all required study plans are in place
o Manage the TMF
o Ensure the study is conducted in compliance with the protocol, GCP and that safety, rights and well-being of patients are preserved
* Collaborate with team members to support milestone achievement and manage study challenges.
* Proactively manage risks and lead efforts to resolve issues.
Qualifications
* Hold an MSc degree or higher in life sciences or equivalent.
* Possess at least 2 years of clinical studies project management experience, or an equivalent combination of education, training, and experience.
* Experience in early phase (FIH) studies and in the field of oncology is desirable.
* Demonstrate knowledge of clinical trial conduct, applying relevant clinical research regulatory requirements such as ICH GCP and local laws, regulations, and guidelines. Possess a GCP qualification of training. Preferentially possess the BROK certificate and ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU.
* Proficient in English. Management of French or Dutch is desirable.
* Have proven experience in managing multi-disciplinary projects and working closely with clinics and research centers.
* Be proficient in Microsoft Office 365 software.
* Be a team player with the ability to work in a small, multi-disciplinary team while also having the capability to work independently with a strong sense of priority.
* Possess excellent organizational, planning, analytical, and conceptual thinking skills with meticulous attention to detail.
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