EU-CTR Manager Role Overview
We are seeking a seasoned professional to manage EU-CTR submissions and document preparation in an office-based setting with occasional travel.
* The ideal candidate will possess strong expertise in EU-CTR, IVDR, Cardiovascular, Renal, Metabolism, or Respiratory fields, with at least 2 years of experience in a similar position within the pharmaceutical or Contract Research Organisation (CRO) industry.
About this Opportunity
This role involves managing country-level start-up activities in compliance with procedures, documents, local, and international guidelines. The successful candidate will be responsible for:
1. Site regulatory documentation preparation, review, tracking, and management at country and site levels.
2. Maintenance, review, and reporting on site performance metrics.
3. Collaboration with CRAs and Local Study Teams to ensure timely and efficient achievement of start-up activities and milestones.
Requirements and Qualifications
* A minimum of 2 years of experience in a similar position (CRO or pharma).
* Good knowledge of international guidelines and relevant local regulations.
* Excellent interpersonal skills.
* Attention to detail.
Benefits and Culture
We offer a diverse culture that rewards high performance and nurtures talent, as well as a competitive salary, array of benefits, including annual leave entitlements, health insurance offerings, retirement planning, and more.