Country Study Start-up Manager / Biopharma

YOUR ROLE

As a Country Study Start-up Manager, you will play a pivotal role in overseeing the timely and quality completion of clinical trial activities up to site activation. Your key responsibilities will include managing local and central ethics committee submissions, ensuring the collection and preparation of essential documents, and acting as the primary contact for study sites to facilitate smooth regulatory communications. Additionally, you will proactively identify potential risks or delays and develop strategies to mitigate these issues, ensuring that the site activation process aligns with our company's mission to accelerate the delivery of innovative therapies to patients. This role's purpose is to address the challenges of timely site readiness, contributing to our vision of bringing medicines to patients faster.

WHO YOU ARE

• 3-5 years of relevant experience in clinical trial start-up processes.
• Strong knowledge of regulatory requirements and ethics committee submissions.
• Excellent communication skills, both verbal and written, in English.
• Proven ability to manage multiple projects and priorities effectively.
• Familiarity with document management systems such as Veeva, SharePoint, CTMS, and eTMF.
• Adaptability and flexibility in a fast-paced, high-volume environment.
• Strong problem-solving skills and a proactive approach to challenges.
• Ability to work independently and collaboratively within a multicultural team.