Job Title: Study Start-Up Specialist - Experienced
Location: Slovakia, homebased
Working with a full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.
- Prepare, review, and file clinical trial applications to country agencies;
- Provide insightful input on regulatory submissions documents and timelines;
- Ensure submissions comply with applicable regulations and guidance documents;
- Advise on changing country regulations and compliance requirements; and
- Track submissions and ensure timely filing of documents.
- A minimum of a Bachelor's degree is required;
- Work experience as Regulatory Submissions Coordinator/Study Start Up Specialist
- Excellent organization and communication skills;
- Fluency in English and Slovak;
- Strong attention to detail; and
- Knowledge of Microsoft® Office.
- Agency: Achieva Group Limited
- Reference: BH-34286
Website: Achieva Group Limited
- Posted: 19th January 2023
- Expires: 16th February 2023