Start-up Project Manager Europe

Future Opportunity : Start-Up Project Manager

At Biomapas, we are continuously expanding our Clinical Trial projects, and this means we are always on the lookout for talented Start-Up Project Manager to join our team. While we may not have an immediate opening, we are proactively seeking experienced Start-Up Project Manager who see themselves as part of our growing team. If you are passionate about clinical research, project leadership, and working in an international environment, we invite you to submit your application today. We will get in touch when a suitable opportunity arises!

As a Start-Up Project Manager you will be responsible for leading and oversight deliverables for clinical trials start-up activities in accordance with ICH GCP, EU CTR requirements CTIS (Part I and Part II), and local countries level regulatory requirements where your expertise will shape operational efficiency.

You must submit your CV in the English language for consideration.

Responsibilities :

• Projects SUPM oversight : manage oversight of start-up activities (starting from feasibility completed till sites' activation) within assigned projects.
• CA and EC submissions management : oversee the preparation and submissions of clinical trial applications under EU CTR and other applicable country level regulatory requirements.
• Site start-up management : supervise sites documents collection for CA and EC submissions and for IP release / essential documents packages.
• Client management : acting as the primary point of contact to the Clients during start-up trials phase, developing trials SSU timelines and submission strategy in collaboration with the clinical Pm and the Client.
• Cross-functional leadership : coordinate trial start-up activities in close cooperation with Clinical Operations, Regulatory Affairs, Contracts & Budgets, Vendor Management departments.
• Risk & Time management : develop and maintain SSU strategy and timelines as per committed to Clients' deliverables. Timely identify potential bottlenecks or study start up processes, suggest and implement mitigations strategies.